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D003920: Diabetes Mellitus

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (53)


Name (Synonyms) Correlation
drug3478 SMBI digital app Wiki 0.17
drug3810 Supported Adopted Intervention 1 Wiki 0.17
drug2204 Low-Carbohydrate Diet Wiki 0.17
Name (Synonyms) Correlation
drug1198 Dexcom G6 Wiki 0.17
drug2763 PF-06882961 20 mg Wiki 0.17
drug3541 Saxagliptin Wiki 0.17
drug3648 Smartphone application LiPAT Wiki 0.17
drug2142 Linagliptin 5 MG Wiki 0.17
drug4505 hospitalisation, necessity of ICU, mortality rate, lung involvement Wiki 0.17
drug1757 Hospital: Usual Care (UC) Wiki 0.17
drug4312 Workshops control group LiPAT Wiki 0.17
drug1987 Intervention for TECC Model Wiki 0.17
drug1642 Glycaemic levels Wiki 0.17
drug3917 Tele-interventions related to diabetes management and mental well-being Wiki 0.17
drug4313 Wrist-worn feedback physical activity monitor Wiki 0.17
drug1958 Interactive workshops LiPAT intervention group Wiki 0.17
drug4748 standard newborn and infant care Wiki 0.17
drug1756 Hospital: DD-CA Wiki 0.17
drug3812 Supported Adopted Intervention 3 Wiki 0.17
drug3034 Post-intensive Care unit syndrome Wiki 0.17
drug2910 Pioglitazone 30 mg Wiki 0.17
drug4573 media package Wiki 0.17
drug4376 antidiabetic treatment Wiki 0.17
drug4299 Weight Counseling Wiki 0.17
drug2319 Mediterranean diet, no caloric restriction Wiki 0.17
drug172 AZD9567 Wiki 0.17
drug1956 Insulin icodec Wiki 0.17
drug304 Anti-Human Thymocyte Immunoglobulin, Rabbit Wiki 0.17
drug4259 Viusid and Asbrip Wiki 0.17
drug1840 Hypocaloric, moderate low fat diet Wiki 0.17
drug3083 Preventive information Wiki 0.17
drug393 Attention Control Intervention 4 Wiki 0.17
drug876 Certified cloth face mask plus preventive information Wiki 0.17
drug4554 lopinavir/ritonavir Wiki 0.17
drug2716 Optical coherence tomography angiography Wiki 0.17
drug2135 Lifestyle App Wiki 0.17
drug2226 MANAGEMENT OF COVID-19 Wiki 0.17
drug3932 Telephone Coaching Wiki 0.17
drug1839 Hypocaloric, low carbohydrate diet Wiki 0.17
drug3067 Prednisolone Wiki 0.17
drug4610 no interventional study Wiki 0.17
drug3811 Supported Adopted Intervention 2 Wiki 0.17
drug3539 Satisfaction evaluation Wiki 0.17
drug697 CFZ533 Wiki 0.17
drug834 Canakinumab Wiki 0.12
drug4749 standard of care Wiki 0.10
drug3928 Telemedicine Wiki 0.09
drug1152 Dapagliflozin Wiki 0.09
drug2696 Online Survey Wiki 0.08
drug2176 Losartan Wiki 0.06
drug4607 no intervention Wiki 0.06
drug2998 Placebos Wiki 0.04
drug2916 Placebo Wiki 0.03

Correlated MeSH Terms (16)


Name (Synonyms) Correlation
D003924 Diabetes Mellitus, Type 2 NIH 0.53
D003922 Diabetes Mellitus, Type 1 NIH 0.44
D044882 Glucose Metabolism Disorders NIH 0.30
Name (Synonyms) Correlation
D008659 Metabolic Diseases NIH 0.26
D004700 Endocrine System Diseases NIH 0.25
D006943 Hyperglycemia NIH 0.12
D018149 Glucose Intolerance NIH 0.10
D011236 Prediabetic State NIH 0.09
D001835 Body Weight NIH 0.09
D051437 Renal Insufficiency, NIH 0.07
D000073496 Frailty NIH 0.06
D050177 Overweight NIH 0.06
D008107 Liver Diseases NIH 0.06
D012140 Respiratory Tract Diseases NIH 0.03
D018352 Coronavirus Infections NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03

Correlated HPO Terms (7)


Name (Synonyms) Correlation
HP:0000819 Diabetes mellitus HPO 1.00
HP:0005978 Type II diabetes mellitus HPO 0.53
HP:0100651 Type I diabetes mellitus HPO 0.44
Name (Synonyms) Correlation
HP:0000818 Abnormality of the endocrine system HPO 0.25
HP:0011998 Postprandial hyperglycemia HPO 0.12
HP:0000083 Renal insufficiency HPO 0.07
HP:0001392 Abnormality of the liver HPO 0.06

Clinical Trials

Navigate: Correlations   HPO

There are 33 clinical trials


1 A Patient-Centered PaTH to Addressing Diabetes: Impact of State Health Policies on Diabetes Outcomes and Disparities

The overarching goal of this proposal is to understand the comparative effectiveness of obesity counseling as covered by CMS in improving weight loss for adults either with or at high risk of type 2 diabetes. CMS and most insurers now include obesity screening and counseling benefits, with no cost sharing to patients. Since overweight patients are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Beneficiaries with obesity are eligible for up to 20 face-to-face visits for weight counseling in the primary care setting. The investigators propose comparing weight and diabetes outcomes in three states using EHR and claims data before and after this policy was implemented by leveraging the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. Following developments during the COVID-19 pandemic, the investigators further plan to leverage our study infrastructure across five health systems to understand the comparative effectiveness of telemedicine approaches for providing outpatient care for patients with or at risk of type 2 diabetes and how these approaches impact the subgroup of patients with COVID-19.

NCT02788903
Conditions
  1. Obesity
  2. Diabetes
  3. Covid19
Interventions
  1. Other: Weight Counseling
  2. Other: Telemedicine
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Weight change during counseling and/or % of weight change during program and maintained over remaining time period will be assessed in both the diabetes and pre-diabetes cohorts.

Measure: Weight change

Time: 10 years

Secondary Outcomes

Description: In the pre-diabetes cohort, diabetes incidence will be determined as the % of patients who develop diabetes following weight counseling. In the diabetes cohort, uncontrolled diabetes will be measured.

Measure: Diabetes Incidence

Time: 10 years

Description: Incidence of hospitalization will be assessed for COVID-19 positive patients

Measure: Hospitalization

Time: 1 year

Description: Incidence of intubation will be assessed for COVID-19 positive patients

Measure: Intubation

Time: 1 year

Description: Incidence of death will be assessed for COVID-19 positive patients

Measure: Death

Time: 1 year
2 Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

Patient-facing eHealth technologies are those that connect patients and the healthcare system, and include online patient portals. Although many organizations are adopting patient portals, there is limited understanding of how the different portal features help improve health outcomes. This study is designed to develop and test an intervention to improve adoption and use of patient portal features for diabetes management.

NCT02953262
Conditions
  1. Diabetes Mellitus
Interventions
  1. Behavioral: Supported Adopted Intervention 1
  2. Behavioral: Supported Adopted Intervention 2
  3. Behavioral: Supported Adopted Intervention 3
  4. Behavioral: Attention Control Intervention 4
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: The investigators will examine the changes in use of MHV from baseline to 6 month follow-up, including use of secure messaging, Blue Button, and prescription refills.

Measure: Changes in My HealtheVet patient portal use

Time: Baseline & 6 month follow up
3 A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age

The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. Dapagliflozin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 40 countries worldwide including the USA and Europe. Saxagliptin (alone or in combination with other antidiabetic drugs) is available for use in adults in approximately 90 countries worldwide. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they haven't been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from the food that is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening phase of up to 6 months if Investigator thinks that some of the screening tests can be repeated, followed by a 2 week lead in phase. Thereafter there will be a 26W short-term treatment phase (W1-26), and a 26 W long-term treatment phase (W27-52). Following this there will be a follow-up telephone call on week 56 and a post study visit at W104. At day 1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, and until the end of the study, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose.Starting at W32 or W40, i.e., after the end of the primary endpoints, patients with background medication of metformin only, and an HbA1c value < 7.5% at W26 or W32, will undergo a third randomization. Eligible subjects from the treatment arms will undergo the randomized withdrawal of background medication, while eligible patients from the placebo arm will undergo, in addition to randomized withdrawal of background medication a randomized switch to active treatment. Short- and long-term period study visits can be delayed by a maximum of 11 months in total. If the duration of investigational product administration is longer than 52 (+1) weeks, the safety follow-up period should be shortened such that the complete study duration does not exceed 104 weeks. The W104 visit should not be delayed.If more than 12 weeks elapse between the HbA1c collection at W26 and the third rand at W32, or the HbA1c collection at W32 and the third rand at W40, the subject should not go through this rand as the HbA1c value would no longer be reliable to ascertain eligibility for the third rand

NCT03199053
Conditions
  1. Diabetes Mellitus, Type 2
Interventions
  1. Drug: Dapagliflozin
  2. Drug: Saxagliptin
  3. Drug: Placebo
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: To determine if there will be a greater mean reduction from baseline in HbA1c achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin 5 mg or saxagliptin 2.5 mg (with titration to the high-dose for those who do not achieve the glycemic target of HbA1c < 7% at 12 weeks) compared to placebo in pediatric T2DM subjects with HbA1c levels of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.

Measure: Change from baseline in HbA1c at Week 26

Time: 26 weeks

Secondary Outcomes

Description: To determine if there will be a greater mean reduction from baseline in Fasting Plasma Glucose (FPG) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin 5 mg or saxagliptin 2.5 mg (with titration to the high-dose for those who do not achieve the glycemic target of HbA1c <7% at 12 weeks) compared to placebo in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin

Measure: Change from baseline in Fasting Plasma Glucose at Week 26

Time: 26 weeks

Description: To compare the percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% after 26 weeks of oral double-blind add-on therapy of dapagliflozin 5 mg or saxagliptin 2.5 mg (with titration to the high-dose for those who do not achieve the glycemic target of HbA1c <7% at 12 weeks) versus placebo in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin

Measure: Percentage of subjects with baseline HbA1c ≥ 7%, who achieve an HbA1c level < 7.0% at Week 26

Time: 26 weeks

Other Outcomes

Description: To compare the percentage of subjects requiring glycemic rescue medication or discontinuing study medication due to lack of efficacy with dapagliflozin or saxagliptin against the percentage with placebo during 26 weeks of oral double-blind add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.

Measure: Percentage of subjects who require glycemic rescue medication or discontinue the study medication due to lack of efficacy during the 26-week treatment period

Time: 26 weeks

Description: To assess the mean change from baseline in HbA1c achieved with dapagliflozin therapy versus placebo, and separately, achieved with saxagliptin therapy versus placebo after 52 weeks of oral blinded add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.

Measure: Change from baseline in HbA1c at Week 52

Time: 52 weeks

Description: To assess the mean change from baseline in FPG achieved with dapagliflozin therapy versus placebo, and separately, achieved with saxagliptin therapy versus placebo after 52 weeks of oral blinded add-on treatment in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin

Measure: Change from baseline in FPG at Week 52

Time: 52 weeks

Description: To assess the percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% after 52 weeks of oral blinded add-on therapy with dapagliflozin versus placebo, or saxagliptin versus placebo in pediatric T2DM subjects with HbA1c of 6.5 to 10.5% on diet and exercise and metformin (IR or XR), insulin, or metformin (IR or XR) plus insulin.

Measure: Percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level < 7.0% at Week 52

Time: 52 weeks
4 The Light Intensity Physical Activity Trial

In type 2 diabetes (T2D), physical activity is an important modifiable risk factor of cardiovascular disease (CVD). Unfortunately (long-term) compliance to exercise programs in patients with T2D is poor. Light-intensity physical activity (LiPA) such as walking slowly, household activities or taking a flight of stairs might be a potential target for lowering the CVD risk in patients with T2D since it can perhaps be more be incorporated into daily life. To assess cardiovascular disease risk in this single-blinded RCT, the investigators settled on measuring arterial stiffness as the primary outcome. Arterial stiffness has independent predictive value for cardiovascular events and can be measured reliably and non-invasively. The investigators hypothesize that light intensity physical activity intervention program based upon increasing LiPA by replacing sedentary time is effective in lowering arterial stiffness as estimated by aortic pulse wave velocity (PWV) and carotid distensibility in individuals with T2D.

NCT03415880
Conditions
  1. Diabetes Mellitus
  2. Physical Exercise
  3. Light Intensity Physical Activity
  4. Arterial Stiffness
  5. Aortic Stiffness
  6. Pulse Wave Velocity
  7. Type2 Diabetes
  8. Sedentary Lifestyle
  9. Artery D
  10. Artery Disease
  11. Physical Activity
Interventions
  1. Behavioral: Interactive workshops LiPAT intervention group
  2. Device: Wrist-worn feedback physical activity monitor
  3. Device: Smartphone application LiPAT
  4. Behavioral: Telephone Coaching
  5. Behavioral: Workshops control group LiPAT
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Aortic (carotid to femoral) PWV will be determined by means of applanation tonometry. It will be calculated as the median of three consecutive PWV recordings.

Measure: The effect of a LiPA intervention program on reducing aortic carotid-to-femoral pulse-wave velocity (PWV) in patients with type 2 diabetes.

Time: Change from baseline PWV at 6 months.

Description: Carotid distensibility will be determined at the left common carotid by means of arterial ultrasound.

Measure: The effect of a LiPA intervention program on increasing carotid distensibility in patients with type 2 diabetes.

Time: Change from baseline carotid distensibility at 6 months.

Secondary Outcomes

Description: Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity).

Measure: Feasibility of a LiPA intervention program on reducing sedentary time as measured by activPAL

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in blood pressure

Measure: The effect of a LiPA intervention on changes in blood pressure.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in waist -circumference

Measure: The effect of a LiPA intervention on waist -circumference in cm.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: The EQ-5D is a short questionnaire that covers five dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety/Depression. The EQ-5D includes 5 questions with 5 answer options each, ranging from 1 ('no problems') to 5 ('severe limitation'). A summary index with a maximum score of 1 can be computed from these five dimensions by means of a converion table. A score of 1 indicates the best health status. Additionally, there is a visual analogue scale (VAS) to indicate the general health status with scores ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').

Measure: The effect of a LiPA intervention on quality of life as measured through the Dutch versions of the EQ-5D questionnaire.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: The PHQ-9 is a self-administered questionnaire based on the DMS-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for a major depressive disorder. It comprises nine items rated on a 4-point scale, ranging from 0 = "not at all" to 3 = "nearly every day". The PHQ-9 scale will also be used as a dichotomous variable with a pre-defined cut-off level of 10, which represents the presence of clinically relevant depressive symptoms.

Measure: The effect of a LiPA intervention on depressive symptoms with the use a validated Dutch version of the 9-item Patient Health Questionnaire (PHQ-9).

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Daily activity levels will be measured by activPAL3™ physical activity monitor. The participants will wear the device fixated on their upper leg for 8 consecutive days at each measurement moment. ActivPAL measures total standing time, sedentary time (sitting or lying down), and stepping time (physical activity). Stepping time (physical activity) is further classified into higher intensity physical activity (minutes with a step frequency >110 steps/min during waking time) and lower intensity physical activity (minutes with a step frequency ≤110 steps/min during waking time).

Measure: Feasibility of a LiPA intervention program on increasing standing and stepping time as measured by activPAL.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in fasting blood glucose.

Measure: The effect of a LiPA intervention on fasting blood glucose

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in HbA1c.

Measure: The effect of a LiPA intervention on HbA1c.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in total cholesterol.

Measure: The effect of a LiPA intervention on total cholesterol.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in HDL- and LDL-cholesterol.

Measure: The effect of a LiPA intervention on HDL- and LDL-cholesterol.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in triglycerides

Measure: The effect of a LiPA intervention on triglycerides.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in glucose lowering medication.

Measure: The effect of a LiPA intervention on glucose lowering medication.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in hip -circumference

Measure: The effect of a LiPA intervention on hip -circumference in cm.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of any changes in body composition as measured by bio electrical impedance.

Measure: The effect of a LiPA intervention on body composition

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: The SF-36 is a generic and easily self-administered quality of life instrument. The SF-36 questionnaire measures health on eight multi-item dimensions, covering functional status, well-being, and overall evaluation of health. In six of these eight dimensions, participants rate their responses on a three or six point scale. For each dimension, item scores are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health).

Measure: The effect of a LiPA intervention on quality of life as measured through the Dutch version of the SF-36 questionnaire.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Measurement of circulating immune cells using flow cytometry from fresh whole blood. In addition, measurement of circulating cytokines to assess the activation state of immune cells, and store immune cells for functional tests.

Measure: The effect of a LiPA intervention program on immune cells.

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).

Description: Microvascular function will be evaluated in both the retina and the skin. Which will be determined with the use of fundoscopy and Skin laser Doppler flowmetry.

Measure: The effect of a LiPA intervention program on microvascular function

Time: Measured at baseline (t=0), after month 3 (t=3), month 6 (t=6) and 12 months after baseline (t=12).
5 Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes

An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches. COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.

NCT03651622
Conditions
  1. Diabetes Mellitus, Type 1
  2. Overweight and Obesity
Interventions
  1. Behavioral: Hypocaloric, low carbohydrate diet
  2. Behavioral: Hypocaloric, moderate low fat diet
  3. Behavioral: Mediterranean diet, no caloric restriction
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1 Overweight
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in weight - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.

Measure: Change in HbA1C - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: Change in the percent of time spent in hypoglycemia during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 1

Time: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit

Description: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 2

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in the percent of time spent in hypoglycemia during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 3

Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit

Secondary Outcomes

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 1

Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 2

Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit

Description: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.

Measure: Change in percent body fat - Randomization 3

Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from CGM insertion at Measurement Visit 2.

Measure: Difference in time spent within target blood glucose range - Randomization 1

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.

Measure: Difference in time spent within target blood glucose range - Randomization 2

Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit

Description: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during CGM wear time, will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.

Measure: Difference in time spent within target blood glucose range - Randomization 3

Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit
6 Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial

The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.

NCT03675360
Conditions
  1. Diabetes
  2. PreDiabetes
  3. Metabolic Disease
  4. Hyperglycemia
  5. Diet Modification
  6. Glucose Intolerance
  7. Glucose Metabolism Disorders (Including Diabetes Mellitus)
  8. Endocrine System Diseases
Interventions
  1. Behavioral: Low-Carbohydrate Diet
MeSH:Diabetes Mellitus Hyperglycemia Prediabetic State Glucose Intolerance Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Hyperglycemia Postprandial hyperglycemia

Primary Outcomes

Measure: Change in Hemoglobin A1c

Time: Baseline and six months

Secondary Outcomes

Measure: Change in fasting plasma glucose

Time: Baseline and six months

Measure: Change in systolic blood pressure

Time: Baseline and six months

Measure: Change in total-to-HDL-cholesterol ratio

Time: Baseline and six months

Measure: Change in body weight

Time: Baseline and six months

Other Outcomes

Measure: Change in insulin

Time: Baseline and six months

Measure: Change in homeostasis model assessment of insulin resistance (HOMA-IR)

Time: Baseline and six months

Measure: Change in diastolic blood pressure

Time: Baseline and six months

Measure: Change in waist circumference

Time: Baseline and six months

Description: Based on 10-year cardiovascular disease risk assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score

Measure: Change in estimated cardiovascular disease risk

Time: Baseline and six months
7 Investigator- and Subject-blinded, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy Trial of CFZ533 in Pediatric and Young Adult Subjects With New Onset Type 1 Diabetes (T1DM)

The study is a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.

NCT04129528
Conditions
  1. Type 1 Diabetes Mellitus
Interventions
  1. Drug: CFZ533
  2. Other: Placebo
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: To evaluate safety and tolerability of CFZ533 in new onset T1DM.

Measure: Proportion of subjects with adverse events (AE)/serious adverse events (SAE) in treatment groups.

Time: at 16 months

Description: To evaluate the treatment effect of CFZ533 on pancreatic beta cell function.

Measure: Stimulated C-peptide AUC by mixed meal tolerance test (MMTT).

Time: at 12 months

Secondary Outcomes

Description: To evaluate the pharmacokinetics (PK) of CFZ533.

Measure: Free CFZ533 plasma concentration.

Time: at day 1

Description: To evaluate the pharmacokinetics (PK) of CFZ533.

Measure: Free CFZ533 plasma concentration.

Time: at 1 week

Description: To evaluate the pharmacokinetics (PK) of CFZ533.

Measure: Free CFZ533 plasma concentration.

Time: at 12 months

Description: To evaluate the treatment effect of CFZ533 on full or partial remission.

Measure: Proportion of subjects with full or partial remission.

Time: at 12 months

Description: To evaluate durability of effects of CFZ533 on pancreatic beta cell function.

Measure: Stimulated C-peptide AUC by MMTT.

Time: at 3 years
8 Prolonged Sedentary Behavior in Older Women With and Without Type 2 Diabetes: Knowledge, Engagement, and Relationship to Cardiometabolic Risk

Sedentary behavior has been linked to cardiovascular morbidity and mortality, and is particularly common in older adults with type 2 diabetes. The purpose of this observational, mixed-methods study is to better understand the relationship between prolonged sedentary behavior and cardiovascular and metabolic health in older women.

NCT04262128
Conditions
  1. Diabetes Mellitus, Type 2
  2. Healthy
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Measure: time sedentary measured via triaxial accelerometer

Time: 7 days

Measure: average sedentary bout length measured via triaxial accelerometer

Time: 7 days

Description: peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test

Measure: cardiorespiratory fitness

Time: 8-12 minutes

Description: glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp

Measure: insulin sensitivity

Time: 3 hours

Measure: change in skeletal muscle deoxygenated hemoglobin concentration during single leg calf exercise measured via near-infrared spectroscopy

Time: 30 minutes
9 "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO

COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death. Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study. The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies. This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

NCT04324736
Conditions
  1. Coronavirus
  2. Diabetes
Interventions
  1. Other: no interventional study
MeSH:Coronavirus Infections Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Prevalence of severe forms among all COVID-19 patients with diabetes

Measure: Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19

Time: 1 month

Secondary Outcomes

Description: Use the body weight, type of diabetes, tglycemic control (HbA1C at admission), the comorbidities and complications associated with diabetes and finally the usual therapies.

Measure: describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: death at 7 days after admission, hospital death and date of death, total length of hospitalization and discharge procedures, serious form requiring the use of artificial ventilation with tracheal intubation and date of use of this treatment, decision to limit

Measure: describe the prognosis of hospitalized subjects with diabetes and COVID-19

Time: 1 month

Description: care service where the patient is taken care of, insulin therapy (IVSE or multi-injection) and dose of insulin required on D2 and D7

Measure: describe the care management of hospitalized subjects with diabetes and COVID-19

Time: 1 month
10 Impact of Tele-Interventions During the COVID-19 Pandemic on Glycemic Control and Attitude Toward the Disease in Patients With Diabetes Mellitus - A Randomized Clinical Trial

INTRODUCTION In critical situations, such as the current COVID 19 pandemic, themes of fear, uncertainty and stigmatization are common and constitute barriers to appropriate medical and mental health interventions. These challenges, when faced by those who live with a chronic disease, such as diabetes mellitus (DM), can negatively influence quality of life and adherence to treatment, compromising the control of the disease. OBJECTIVES The present study aims to investigate the effectiveness of a tele-intervention during the COVID-19 pandemic in improving glycemic control, lipid profile, blood pressure levels and parameters of medication adherence, mental well-being and sleep quality in patients with type 1 DM and type 2 DM. METHODS A randomized clinical trial will be carried out with patients with a previous diagnosis of type 1 DM and type 2 DM, who are registered at the Hospital de Clínicas de Porto Alegre (HCPA). Inclusion criteria will be age greater than or equal to 18 years, collection of HbA1c in the HCPA laboratory in January, February or March 2020 and availability to receive weekly phone calls. Patients will be randomized, stratified by type of diabetes, in two groups: G1: participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the social distancing period ; G2: participants will receive the usual care. The primary outcome assessed will be the variation in HbA1c levels comparatively between groups, with or without a tele-guided strategy, after four months of social distancing (or as long as the recommendation of social distancing measures remains). Secondary outcomes will include experiencing confirmation of COVID-19 infection, variation in lipid profile, blood pressure levels and variation in parameters of emotional distress related to diabetes, eating disorders, medication adherence, symptoms minor psychiatric disorders and altered sleep patterns, which will be evaluated with specific and validated scales. According to the sample calculation, 150 patients will be included in the study (92 with type 2 DM and 58 with type 1 DM). Analysis by intention to treat will be performed separately for patients with type 1 DM and with type 2 DM. SCHEDULE The proposed experiment will start immediately after approval of this project by the research ethics committee. The duration of the proposed intervention is 4 months (or as long as the recommendation of social distancing measures remains. This means that the study may be completed before or after that period, based on national recommendations for social distancing in Brazil), with a data analysis plan and publication of the results until September 2020.

NCT04344210
Conditions
  1. COVID
  2. Diabetes Mellitus, Type 2
  3. Diabetes Mellitus, Type 1
Interventions
  1. Behavioral: Tele-interventions related to diabetes management and mental well-being
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Variation in HbA1c levels comparatively between groups after the period of social distancing measures.

Measure: Variation in HbA1c levels

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Secondary Outcomes

Description: Confirmation of coronavirus infection by rapid test

Measure: COVID-19 infection

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Comparison of the lipid profile of the last year with the lipid profile after the intervention between the groups.

Measure: Variation in lipid profile

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Comparison of the blood pressure level of the last consultation with the pressure after the intervention between the groups.

Measure: Variation in blood pressure levels

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Evaluation of emotional distress associated with the routine of living with diabetes - B-PAID (Brazilian Problem Areas In Diabetes Scale)

Measure: Comparison of emotional distress associated with the routine of living with diabetes after intervention between groups

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Evaluation of eating disorders - EAT - 26 SCALE (Teste de Atitudes Alimentares)

Measure: Comparison of eating disorders between groups

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Evaluation of adherence to the proposed clinical treatment - SCI R (Self-Care Inventory - revised)

Measure: Comparison of adherence to the proposed clinical treatment between groups

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Evaluation of minor psychiatric disorders - SRQ 20 (Self Report Questionnaire)

Measure: Comparison of minor psychiatric disorders between groups

Time: 4 months (or as long as the recommendation of social distancing measures remains)

Description: Evaluation of sleep pattern changes - MSQ (Mini Sleep Questionnaire)

Measure: Comparison of sleep pattern changes between groups

Time: 4 months (or as long as the recommendation of social distancing measures remains)
11 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

The coronavirus disease 2019 (COVID-19) is an emerging pandemic in 2020 caused by a novel coronavirus named SARS-CoV2. Diabetes confers a significant additional risk for COVID-19 patients. Dipeptidyl peptidase 4 (DPP-4) is a transmembrane glycoprotein expressed ubiquitously in many tissues. In addition to its effect on glucose levels, DPP-4 has various effects on the immune system and several diseases, including lung diseases. This trial aims to assess the safety and efficacy of linagliptin, a DPP-4 inhibitor, in the treatment of COVID-19. The trial will be randomized without blinding, with one are treated by insulin only for glucose balance and the other by insulin and linagliptin. The trial will assess the effects of linagliptin on different measures of COVID-19 recovery.

NCT04371978
Conditions
  1. COVID 19
  2. Coronavirus
  3. Diabetes Mellitus, Type 2
  4. Diabetes Mellitus
  5. Glucose Metabolism Disorders
  6. Metabolic Disease
  7. Endocrine System Diseases
  8. Dipeptidyl-Peptidase IV Inhibitors
  9. Linagliptin
  10. Severe Acute Respiratory Syndrome Coronavirus 2
  11. Sars-CoV2
  12. Hypoglycemic Agents
  13. Respiratory Tract Diseases
  14. Incretins
  15. Hormones
Interventions
  1. Drug: Linagliptin 5 MG
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Tract Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Clinical change is defined as 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19: 0 - No clinical or virological evidence of infection; 1 - No limitation of activities; 2 - Limitation of activities; 3 - Hospitalized, no oxygen therapy; 4 - Oxygen by mask or nasal prongs; 5 - Non-invasive ventilation or high-flow oxygen; 6 - Intubation and mechanical ventilation; 7 - Ventilation + additional organ support - pressors, renal replacement therapy, extracorporeal membrane oxygenation; 8 - Death.

Measure: Time to clinical change

Time: 28 days

Secondary Outcomes

Measure: Percent of serious adverse events and premature discontinuation of treatment.

Time: 28 days

Description: Percent of patients with a 2 points reduction in the World Health Organization (WHO) Ordinal Scale for Clinical Improvement of COVID-19.

Measure: Percent of patients with clinical improvement.

Time: 28 days

Measure: Length of hospitalization.

Time: 28 days

Measure: All-cause mortality.

Time: 28 days

Measure: Percent of supplemental oxygen use.

Time: 28 days

Measure: Supplemental oxygen-free days.

Time: 28 days

Measure: Percent of mechanical ventilation use.

Time: 28 days

Measure: Ventilator-free days.

Time: 28 days

Measure: Percent of ICU admissions.

Time: 28 days

Measure: ICU-free days.

Time: 28 days

Measure: Percent of 50% decrease in C-reactive protein (CRP) levels

Time: Up to 28 days

Measure: Time to virologic response, defined as no detection of SARS-CoV-2 in a PCR test.

Time: 28 days
12 Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients in Teodoro Maldonado Carbo Specialty's Hospital Infected and Diagnosed by SARS-Cov-2 With COVID-19

This is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease caused by 2019 coronavirus infection. Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care and 20 control patients with standard of care. Treatment duration: 21 days.

NCT04407182
Conditions
  1. Covid-19
  2. Sars-CoV2
  3. Diabete Mellitus
  4. Cardiopathy
  5. Pulmonary Disease
  6. Renal Disease
  7. Liver Diseases
Interventions
  1. Dietary Supplement: Viusid and Asbrip
MeSH:Liver Diseases Diabetes Mellitus
HPO:Abnormality of the liver Decreased liver function Diabetes mellitus Elevated hepatic transaminase

Primary Outcomes

Description: The number of days required to achieve a score of 0 for each symptom category. Resolution of symptoms: fever (time frame: 21 days) Fever based on a 0-3 scale: 0 = ≤98.6, 1 => 98.6- 100.6, 2 => 100.6 - 102.6, 3 => 102.6 Resolution of symptoms: cough (time frame: 21 days) Cough based on a 0-3 scale: 0 = no cough, 1 = mild, 2 = moderate, 3 = severe Resolution of symptoms: shortness of breath (time frame: 21 days) Shortness of breath based on a 0-3 scale: 0 = no shortness of breath, 1 = with moderate intensity exercise 2 = walking on a flat surface 3 = shortness of breath when dressing or doing daily activities Resolution of symptoms: fatigue (period: 21 days) Fatigue based on a 0-3 scale: 1 = mild fatigue, 2 = moderate fatigue, 3 = severe fatigue. Composite score that includes all symptoms: (time frame: 21 days) Total composite score of symptoms on days 5, 10, 15, and 21 of study supplementation.

Measure: Symptom resolution

Time: 21 days

Secondary Outcomes

Description: Disease severity will be measured using a disease severity clinical event scale (assessed until day 21) Change from baseline in the patient's health status on an ordinal scale of 7 categories (time frame: days 3, 7, 14, 21) death Hospitalized, with invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, with non-invasive ventilation or high-flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, which does not require supplemental oxygen Not hospitalized, limitation of activities. Not hospitalized, without limitations in activities. Note: lower scores mean a worse result.

Measure: Cumulative incidence of disease severity

Time: 21 days

Description: Differences in the number of patients who received complementary medications for diagnosis between the study arms.

Measure: Complementary drugs required

Time: 21 days

Description: Differences in the number of patients in the study groups experiencing side effects of the supplements.

Measure: Side effects of supplementation

Time: 21 days

Description: PCR analysis at day 0, 7th, 14th and 21th to measure and compare viral load

Measure: Duration of SARS-CoV-2 PCR positivity

Time: 21 days

Description: Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th

Measure: Concentration of reactive protein c in peripheral blood

Time: 21 days

Description: Number of Incidence of hospitalization

Measure: Incidence of hospitalization

Time: 21 days

Description: Number of days of hospitalization

Measure: Duration (days) of hospitalization

Time: 21 days

Description: Number of Incidences of mechanical ventilation supply per patient

Measure: Incidence of mechanical ventilation supply

Time: 21 days

Description: Number of days with mechanical ventilation supply

Measure: Duration (days) of mechanical ventilation supply

Time: 21 days

Description: Number of incidences of oxygen use

Measure: Incidence of oxygen use

Time: 21 days

Description: Number of days of oxygen use per patient

Measure: Duration (days) of oxygen use

Time: 21 days

Description: Number of death per group

Measure: Mortality rate

Time: 21 days

Description: Number of days patient need to recover from disease

Measure: Time to return to normal activity

Time: 21 days

Other Outcomes

Description: Change from baseline in serum cytokine IL-1 level by blood biochemical analysis at day 0, 3, 7, 14 and 21

Measure: Change from baseline in serum cytokine levels

Time: 21 days

Description: Change from baseline in serum cytokine IL-6 level by blood biochemical analysis at day 0, 3, 7, 14 and 21

Measure: Change from baseline in serum cytokine levels

Time: 21 days

Description: Change from baseline in serum cytokine TNF-α level by blood biochemical analysis at day 0, 3, 7, 14 and 21

Measure: Change from baseline in serum cytokine levels

Time: 21 days

Description: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages by blood biochemical analysis at day 0, 3, 7, 14 and 21

Measure: Change from baseline in CCR5 receptor occupancy levels for Tregs and macrophages

Time: 21 days

Description: Change from baseline in CD3 +, CD4 + and CD8 + T cell counts by blood biochemical analysis at day 0, 3, 7, 14 and 21.

Measure: Change from baseline in CD3 +, CD4 + and CD8 + T cell counts

Time: 21 days

Description: Change in liver function test (AST, ALT and TBIL) by blood biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in liver function test

Time: 21 days

Description: Change in kidney function with eGFR rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in kidney function test

Time: 21 days

Description: Change in kidney function with creatine clearance rate by blood and urinary biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in kidney function test

Time: 21 days

Description: Change in routine blood test red blood cells concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in routine blood test

Time: 21 days

Description: Change in routine blood test white blood cell concentration by blood biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in routine blood test

Time: 21 days

Description: Change in routine blood test D-dimer level by blood biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in routine blood test

Time: 21 days

Description: Change in routine blood test fibrinogen level by blood biochemical analysis at day 0, 4, 7, 14 and 21.

Measure: Change in routine blood test

Time: 21 days

Description: Change in myocardial enzyme CPK-MB by blood biochemical analysis at daty 0, 4, 7, 14 and 21

Measure: Change in myocardial enzymes

Time: 21 days

Description: Change in myocardial enzymes troponins by blood biochemical analysis at daty 0, 4, 7, 14 and 21

Measure: Change in myocardial enzymes

Time: 21 days
13 Glycaemia and Cardiac Function in Patients With COVID-19

The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort). The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.

NCT04410718
Conditions
  1. Diabetes Mellitus
  2. Diabetes Mellitus, Type 2
  3. Diabetes Mellitus, Type 1
  4. COVID
Interventions
  1. Other: Glycaemic levels
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)

Measure: Plasma glucose levels and left ventricular ejection fraction

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Secondary Outcomes

Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)

Measure: Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort)

Measure: Plasma glucose levels and strain analysis

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort)

Measure: Plasma glucose levels and mitral annular systolic velocity

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively

Measure: Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively

Measure: Plasma glucose levels and strain analysis (sub-group analysis)

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively

Measure: Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)

Measure: HbA1c, Plasma glucose levels and strain analysis

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c ≤53 mmol/l) (ICU cohort only)

Measure: HbA1c, Plasma glucose levels and mitral annular systolic velocity

Time: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).

Description: Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only)

Measure: Diabetes status and whole blood coagulability and fibrinolysis

Time: At time of admission to the ICU (max. 24 hours after admission to the ICU)

Description: Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only)

Measure: Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay

Time: From first until last assessment during ICU stay (max. 24 hours).

Description: The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death

Measure: Prognostic value of TEG analysis

Time: From time of admission and until four weeks after admission

Description: The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death

Measure: Prognostic value of cardiac function

Time: From time of admission and until four weeks after admission

Description: Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)

Measure: Diabetes status and high-sensitivity troponins

Time: At the time of admission to the ICU (max. 24 hours after admission to the ICU)

Description: Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only)

Measure: Diabetes status and change high-sensitivity troponins

Time: From first until last assessment during ICU stay (max. 24 hours)
14 Prevalence of Diabetes Among Hospitalized Patients With Covid-19 in West of Algeria. Identification of Diabetes-related Associated Factors Severe Forms

By Jan 7, 2020, Chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. The WHO designated later this virus as COVID-19 (coronavirus disease 2019). This exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. Algeria was part of the 13 top priority countries identified by WHO based on their direct links and volume of travel to the infected provinces in China. It is known that some predisposing conditions lead to a worse outcome with coronavirus. In China, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). In Italy, the most common comorbidities associated with death from COVID-19 were hypertension (73.8%) and diabetes (33.9%). The US Centers for Disease Control and Prevention suggests diabetes is the most common comorbidity in COVID-19 cases. In the largest cohort NHS England study, death from COVID-19 was strongly associated with uncontrolled diabetes (after full adjustment, HR 2.36). The West Algerian CORODIAB-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with Covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. In the future, this study will provide answers for two main questions 1. Why diabetics are more at risk of developing Covid-19 infection? 2. Why diabetics are at high risk of developing severe forms?

NCT04412746
Conditions
  1. Coronavirus Infections
  2. Diabetes Mellitus
  3. Prevalence
  4. Risk Factors
  5. Patient Outcome Assessment
  6. Severe Acute Respiratory Syndrome
Interventions
  1. Drug: MANAGEMENT OF COVID-19
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Assess the prevalence of diabetes among hospitalized patients with Covid-19 in Area of Tlemcen

Measure: Prevalence of diabetes among all hospitalized COVID-19

Time: 3 months

Description: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19

Measure: Diabetes-related factors risk

Time: 3 months
15 Remote Glucose Monitoring of Patients With Diabetes Quarantined During the COVID-19 Pandemic - a Hospital-Based Randomized Controlled Trial of the Effect of Remote Continuous Glucose Monitoring Compared to Usual Glucose Monitoring

This is a randomized controlled trial of isolated patients with diabetes admitted to Nordsjællands Hospital with or without COVID-19-pneumonia. A continuous glucose monitoring (CGM) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. Blinded (to patients) CGM is mounted in the finger-prick group.

NCT04430608
Conditions
  1. Diabetes
  2. Covid-19
  3. Infection
Interventions
  1. Device: Dexcom G6
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: TIR is presented in percent of time in which the participants' glucose values are in different glucose ranges.

Measure: Time In Range (TIR) for blood glucose

Time: 1-2 weeks

Secondary Outcomes

Description: Saved patient-personnel contacts related to blood glucose measurements, incl. time healthcare providers spent on diabetes related tasks and PPE related tasks, during the patients' hospitalization.

Measure: Saved patient-personnel contacts related to blood glucose measurements.

Time: 1-2 weeks

Description: Additional glucose outcomes based on data from Dexcom G6 are for example Time Above Range (TAR), Time Below Range (TBR), average glucose, variance in glucose (CV), etc.

Measure: Glucose variations during hospitalization

Time: 1-2 weeks

Description: That is: Tablet-based and insulin-based regimens and number of times that sliding scale insulin (including dose of insulin) has been administered for each patient.

Measure: Blood glucose lowering interventions

Time: 1-2 weeks

Description: Number of techincal errors during the sensors lifetime.

Measure: CGM sensor performance

Time: 1-2 weeks

Description: Hospital death (yes/no), length of stay at hospital, need for respiratory support (yes/no) and intensive care (yes/no), recovered vs. fatal (death within 60 days from admission).

Measure: Course of hospital stay.

Time: 1-2 weeks
16 Effect of Behavioral Lifestyle Intervention on Frailty in Older Adults With Diabetes: A Pilot Study

The study team want to see if changes in lifestyle and behaviors and self-monitoring of diet and physical activity in older adults who have type 2 Diabetes (T2D) may help to prevent or reduce frailty. Frailty occurs in older adults and leads people to have falls, become disabled, require nursing home placement, and have increased risk of death. T2D is one of the major risk factors for frailty. T2D is a significant problem in older adults and is known to increase the risk of future frailty.

NCT04440449
Conditions
  1. Frailty
  2. Weight, Body
  3. Type 2 Diabetes
Interventions
  1. Behavioral: Lifestyle App
MeSH:Diabetes Mellitus Frailty Body Weight
HPO:Diabetes mellitus

Primary Outcomes

Description: Change in frailty measured on a scale using a frailty score (0, 1, 2, 3, 4,or 5), with higher scores out of 5 representing greater frailty. Assessments used for scoring include 1) self reported weight loss, 2) self-reported exhaustion 3) low physical activity based on the Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ) 4) Handgrip strength 5) 10 foot walk pace

Measure: Frailty Scale

Time: Baseline to 6 months

Secondary Outcomes

Description: Change in HbA1c measured over the study period

Measure: Glycated hemoglobin (HbA1c)

Time: Baseline to 6 months

Description: For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured.

Measure: Patient-Reported Outcomes Measurement Information System (PROMIS)

Time: Baseline to 6 months

Description: The study team will administer the Short Physical Performance Battery (SPPB)69 to assess three lower extremity tasks; 1) standing balance (ability to stand with the feet together in side-by-side, semi-and full-tandem positions for 10 seconds each); 2) a 4-meter walk to assess usual gait speed; 3) time to complete 5 repeated chair stand. Each of the 3 performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create a score ranging from 0 to 12 (best). The SPPB is sensitive to change over time

Measure: Short Physical Performance Battery (SPPB)

Time: Baseline to 6 months
17 Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care. This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.

NCT04485351
Conditions
  1. Diabetes Mellitus
  2. Coronavirus Infection
  3. Metabolic Disease
  4. Glucose Metabolism Disorders
Interventions
  1. Other: no intervention
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders
HPO:Diabetes mellitus

Primary Outcomes

Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.

Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.

Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown

Secondary Outcomes

Description: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records

Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy

Time: 6 weeks period following the end of the lockdown

Description: Use BMI, lipid profile, renal and hepatic function from medical records

Measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.

Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown

Description: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization

Measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation

Measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco

Measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)

Measure: Describe healthcare consumption of patients with diabetes during the lockdown.

Time: 6 weeks period following the end of the lockdown

Description: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.

Measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.

Time: 6 weeks period following the end of the lockdown
18 Determining the Impact of COVID-19 Lockdown on Metabolic Control in Individuals With Type 2 Diabetes

The strict rules applied in Italy during the recent COVID-19 pandemic, with the prohibition to attend any regular outdoor activity, are likely to influence the degree of metabolic control of patients with type 2 diabetes. The aim of this observational, prospective, single centre study was to evaluate the immediate impact of the lockdown rules on the metabolic profile of a cohort of patients with type 2 diabetes.

NCT04501991
Conditions
  1. Type 2 Diabetes
  2. Metabolic Control
Interventions
  1. Other: antidiabetic treatment
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Blood glucose was expressed in mg/dl and was determined by standard techniques.

Measure: Glucose

Time: One week after the end of the lockdown period

Description: HbA1c was expressed as percentage or mmol/l and was determined by standard techniques.

Measure: HbA1c

Time: One week after the end of the lockdown period

Description: Complete lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol, Triglcerydes) were expressed in mg/dl or mmol/l and were determined by standard techniques.

Measure: Lipid profile

Time: One week after the end of the lockdown period
19 MELD-ATG: Phase II, Dose Ranging, Efficacy Study of Anti-thymocyte Globulin (ATG) Within 6 Weeks of Diagnosis of Type 1 Diabetes (T1D)

A phase II, Multi-centre, randomised, double-blind, placebo-controlled, Multi-arm parallel cohort trial. - to investigate the effect of 2.5 mg/kg og ATG on the preservation of stimulated C-peptide at 12 months compared to placebo - to identify the minimally effective dose of ATG that shows an effect on C-peptide when compared to placebo at 12 months

NCT04509791
Conditions
  1. Diabetes Mellitus, Type 1
Interventions
  1. Drug: Anti-Human Thymocyte Immunoglobulin, Rabbit
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Measure: the area under the stimulated C-peptide response curve

Time: over the first 2 hours of a MMTT [ mixed meal tolerance test] at 12 months post treatment

Secondary Outcomes

Measure: the area under the stimulated C-peptide response curve

Time: over teh first 2 hours of a MMTT at baseline, 3, 6 and 12 months

Measure: DBS [dry blood spot] C-peptide measurements

Time: at all observation times

Measure: CD4 positive T cells and CD8 positive T cells

Time: over 12 months

Measure: HBA1c

Time: over 12 months

Measure: insulin require months

Time: over 12 months

Measure: T1D-associated autoantibodies ( GADA [glutamic acid decarboxylase antibodies], IAA [insulin auto-antibodies], IA-2A [IA-2 antibodies] and ZnT8A

Time: over 12 months

Measure: CGM [continuous glucose monitoring] measurements ( time in range, time above time below)

Time: over 12 months
20 Canakinumab in Patients With COVID-19 and Type 2 Diabetes - CanCovDia Trial

The purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).

NCT04510493
Conditions
  1. Coronavirus Infection
  2. Diabetes Mellitus, Type 2
Interventions
  1. Drug: Canakinumab
  2. Drug: Placebo
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Treatment and placebo will be compared on the basis of the unmatched win-ratio approach of Pocock. When comparing two patients, the winner will be determined by the first component in which the two patients differ (4 weeks after randomization): longer survival time longer ventilation-free time longer ICU-free time shorter hospitalization time If there is no difference between treatment and Placebo: the win ratio is 1. If there is a difference between treatment and Placebo: the win ratio is not 1.

Measure: unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint)

Time: within 4 weeks after treatment with canakinumab or placebo

Secondary Outcomes

Description: Time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever comes first. "The seven-category ordinal scale consists of the following categories: not hospitalized with resumption of normal activities; not hospitalized, but unable to resume normal activities; hospitalized, not requiring supplemental oxygen; hospitalized, requiring supplemental oxygen; hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and death"

Measure: Time to clinical improvement

Time: From randomization up to 4 weeks

Description: Death rate during the 4-week period after study treatment

Measure: Death rate

Time: 4 weeks

Description: Admission to the intensive care unit from the medical ward during the 4-week period after study treatment

Measure: Admission to intensive care unit (ICU)

Time: 4 weeks

Description: Secondary worsening of disease (i.e., development of Acute respiratory distress Syndrome (ARDS), increase of oxygen demand after 72h of treatment)

Measure: Secondary worsening of disease

Time: 4 weeks

Description: Prolonged hospital stay > 3 weeks

Measure: Prolonged hospital stay

Time: >3 weeks

Description: Ratio to baseline in the glycated hemoglobin

Measure: Change in ratio to baseline in the glycated hemoglobin

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the fasting glucose

Measure: Change in ratio to baseline in the fasting glucose

Time: Baseline, Day 29

Description: Ratio to baseline in the fasting insulin

Measure: Change in ratio to baseline in the fasting insulin

Time: Baseline, Day 29

Description: Ratio to baseline in the fasting c-peptide

Measure: Change in ratio to baseline in the fasting c-peptide

Time: Baseline, Day 29

Description: Ratio to baseline in the C-reactive protein (CRP)

Measure: Ratio to baseline in the C-reactive protein (CRP)

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the D-dimer

Measure: Change in ratio to baseline in the D-dimer

Time: Baseline, Day 29

Description: Ratio to baseline in the Natriuretic peptide (NTproBNP)

Measure: Change in ratio to baseline in the Natriuretic peptide (NTproBNP)

Time: Baseline, Day 29 and Day 90

Description: Ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

Measure: Change in ratio to baseline in the Glomerular Filtration Rate Renal (eGFR)

Time: Baseline, Day 29 and Day 90

Description: Type of antidiabetic treatment at Day 29

Measure: Type of antidiabetic treatment at Day 29

Time: Day 29

Description: Number of antidiabetic treatment at Day 29

Measure: Number of antidiabetic treatment at Day 29

Time: Day 29

Description: Type of antidiabetic treatment at three months

Measure: Type of antidiabetic treatment at three months

Time: Month 3

Description: Number of antidiabetic treatment at three months

Measure: Number of antidiabetic treatment at three months

Time: Month 3
21 Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt: A Pilot Study

During the current unusual situation with COVID-19 pandemic and the lockdown applied in most of the countries, school students were kept at home and offered e-learning modules and all activities were suspended. Lockdown entails significant modifications of life style, involving changes in physical activities, dietary habits and nutrition, which are likely to impact glycemic control. So the aim of the current study is to evaluate the impact of COVID-19 pandemic on glycemic control among children and adolescents with type 1 diabetes.

NCT04531111
Conditions
  1. Type 1 Diabetes
  2. Covid19
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: Change in HbA1c from baseline to 3 month after the lockdown

Measure: Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes

Time: 12 weeks

Secondary Outcomes

Description: Change in total insulin dosage from baseline to 3 month after the lockdown

Measure: Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes

Time: 12 weeks
22 Non-blinded, Randomized and Controlled Clinical Trial of Pioglitazone Treatment in Patients With Type 2 Diabetes Mellitus and Covid-19

The treatment with pioglitazone added to the standard treatment of patients with DM2 hospitalized for COVID-19 may produce a decrease in the number of patients who progress to a second phase of severe systemic inflammation.

NCT04535700
Conditions
  1. Type 2 Diabetes
Interventions
  1. Drug: Pioglitazone 30 mg
  2. Other: standard of care
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: Number of patients receive pioglitazone treatment during their hospital stay who receive support with mechanical ventilation, enter the ICU and / or die.

Measure: Patients treated with pioglitazone, together with conventional treatment for COVID-19 infection, who during their admission evolve towards the need to receive support with mechanical ventilation, enter the ICU and / or die.

Time: Through hospitalization period, an average of 10-20 days until hospital discharge

Secondary Outcomes

Description: Proportion of patients who develop heart failure or adverse reaction associated with treatment.

Measure: Incidence of pioglitazone treatment-Emergent Adverse Events in patients with DM2 and symptomatic SARS-CoV-2 infection.

Time: Everyday through hospitalization period, an average of 10-20 days until hospital discharge

Description: Changes in this inflammation parameter: C-reactive protein (in mg/dl)

Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge

Description: Changes in this inflammation parameter: D-dimer (in μg/mL)

Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge

Description: Changes in this inflammation parameter: ferritin (in ng/mL)

Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge

Description: Changes in this inflammation parameter: creatine kinase (CK) (in mg/dL)

Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge

Description: Changes in this inflammation parameter: number of lymphocytes (in μL)

Measure: Biomarker analysis: systemic inflammation parameters during the administration of pioglitazone treatment.

Time: Each 48 hours through hospitalization period, an average of 10-20 days until hospital discharge
23 Clinical Characteristics and Outcome of Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic: Data From a Single Center Surveillance Study in Egypt

Although reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.

NCT04536285
Conditions
  1. Type 1 Diabetes
  2. Covid19
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: complications and comorbidities associated with diabetes

Measure: Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

Time: 4 months

Description: Acute phase reactants

Measure: Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

Time: 4 months

Description: Intensive care admission

Measure: Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.

Time: 4 month

Secondary Outcomes

Description: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents

Measure: Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents

Time: 4 months

Description: Impact of Covid-19 pandemic on presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes

Measure: Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt

Time: 4 month
24 Clinical Phenotype and Outcomes of Inpatients With COVID-19 and Diabetes

Patients with diabetes have been listed as people at higher risk for severe illness from COVID-19. Moreover, the relationship between diabetes-related phenotypes and the severity of COVID-19 remains unknown. This observational study aims to to evaluate the risk of disease severity and mortality in association with diabetes in COVID-19 inpatients and identify the clinical and biological features associated with worse outcomes.

NCT04550403
Conditions
  1. Diabetes Mellitus
  2. Covid19
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: to assess risk of intensive care unit admission and/or death among COVID-19 inpatients

Measure: prevalence of intensive care unit admission and/or in-hospital mortality among COVID-19 inpatients

Time: february 23 to march 31, 2020

Secondary Outcomes

Description: to compare risk of death among inpatients in presence or absence of diabetes

Measure: prevalence of death among COVID-19 inpatients with and without diabetes

Time: february 23 to march 31, 2020

Description: to compare intensive care unit admission among inpatients in presence or absence of diabetes

Measure: prevalence of intensive care unit admission among COVID-19 inpatients with and without diabetes

Time: february 23 to march 31, 2020

Description: to identify socio-demographic as predictors of severe prognosis (death or intensive care unit admission) during hospitalization

Measure: demographic and clinical characteristics (age,gender, comorbidity status) and death and/or intensive care unit admission during hospitalization

Time: february 23 to march 31, 2020

Description: to identify laboratory variables as predictors of severe prognosis (death or intensive care unit admission) during hospitalization

Measure: laboratory parameters (glycated hemoglobin, glucose at admission, renal and liver function markers, blood count, inflammatory markers, hemostasis) and death and/or intensive care unit admission during hospitalization

Time: february 23 to march 31, 2020

Description: to identify pharmacological therapies as predictors of severe prognosis (death or intensive care unit admission) during hospitalization

Measure: pharmacological therapies and death and/or intensive care unit admission during hospitalization

Time: february 23 to march 31, 2020

Description: to compare total length of hospitalization in patients with or without diabetes

Measure: number of days of hospitalization in patients with and without diabetes

Time: february 23 to march 31, 2020
25 A Phase 2a Randomised, Double Blind, Multi-centre Study to Assess the Effect on Glucose Homeostasis of Two Dose Levels of AZD9567, Compared to Prednisolone, in Adults With Type 2 Diabetes

The study is intended to assess the effect on glycaemic control of AZD9567, as measured by the glucose AUC(0-4) versus baseline following a standardised mixed meal tolerance test (MMTT), compared to prednisolone in adults with type 2 diabetes mellitus (T2DM). The study will also evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD9567.

NCT04556760
Conditions
  1. Diabetes Mellitus, Type 2
Interventions
  1. Drug: AZD9567
  2. Drug: Prednisolone
  3. Other: Placebo
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: The change from baseline in glucose AUC(0-4) will be analysed using a mixed model repeated measures (MMRM) with baseline included as covariate.

Measure: Change in glucose AUC(0-4) versus baseline compared to prednisolone following a standardised MMTT

Time: On Days -1, 4, 27, and 31

Secondary Outcomes

Description: The mean daily glucose will be analysed using a MMRM analysis with baseline as covariate.

Measure: Mean daily glucose at 48 - 72 hours treatment as determined from multiple measures via the Continuous Glucose Monitoring (CGM) system

Time: On Days -2, 3, 26 and 30

Description: The mean daily glucose will be analysed using an MMRM analysis with baseline as covariate.

Measure: Rise in mean daily glucose over 24-hour periods from start of IMP dosing (0 - 24 hours, 24 - 48 hours, 48 - 72 hours)

Time: On Days 1, 2, 3, 28, 29, 30

Description: Pharmacodynamic effects of AZD9567 will be evaluated as compared to prednisolone.

Measure: Change from baseline in fasting glucose

Time: On Days -1, 4, 27, and 31

Description: Effects on insulin, glucagon, GLP-1 and GIP of AZD9567 following MMTT in comparison to prednisolone will be assessed.

Measure: Change from baseline AUC(0-4) on hormones related to glucose homeostasis

Time: On Days -1, 4, 27, and 31

Description: Pharmacodynamic effects of AZD9567 on glucose homeostasis through a MMTT in comparison to prednisolone will be assessed.

Measure: Change from baseline in AUC(0-4) on C-peptide

Time: On Days -1, 4, 27, and 31

Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.

Measure: MMTT derived first phase insulin response

Time: On Days -1, 4, 27, and 31

Description: The concentration of potassium in urine will be measured over 24 hours.

Measure: 24-hour potassium concentration

Time: On Days -1, 3, 27 and 30

Description: The concentration of sodium in urine will be measured over 24 hours.

Measure: 24-hour sodium concentration

Time: On Days -1, 3, 27 and 30

Description: AUClast will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Area under the plasma concentration versus time curve from zero to the last quantifiable concentration (AUClast)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: AUC(0-24) will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Area under the plasma concentration versus time curve from zero to 24 hours post-dose [AUC(0-24)]

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: AUC(0-6) will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Area under the plasma concentration versus time curve from zero to 6 hours post-dose [AUC(0-6)]

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: Cmax will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Maximum observed drug concentration (Cmax)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: Tmax will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Time to reach maximum observed drug concentration (tmax)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: t½λz will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Terminal elimination half-life (t½λz)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: CL/F will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Apparent total body clearance of drug from plasma after extravascular (CL/F)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: Vz/F will be derived using standard non-compartmental methods using WinNonLin version 8.1 or higher (Certara).

Measure: Apparent volume of distribution following extravascular administration (Vz/F)

Time: On Days 3, 4, 30, and 31 (Pre-dose, Post-dose 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30 hours)

Description: Relationship between AZD9567 exposure and inhibition of LPS-stimulated TNFα release for high and low dose comparison (Cohort 1 and Cohort 2) will be assessed.

Measure: TNFα concentrations

Time: On Days 3 and 30 (Pre-dose, Post-dose 1, 2, 4, 8, 12, and 24 hours

Description: Pharmacodynamic effects of AZD9567 will be evaluated following a MMTT compared to prednisolone.

Measure: Change in free fatty acids

Time: On Days -1, 4, 27, and 31

Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.

Measure: Homeostatic model assessment- insulin resistance (HOMA-IR)

Time: On Days -1, 4, 27, and 31

Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.

Measure: HOMA-insulin sensitivity

Time: On Days -1, 4, 27, and 31

Description: Pharmacodynamic effects of AZD9567 on derived measures of beta cell function from the MMTT compared to prednisolone will be evaluated.

Measure: Modified Matsuda index

Time: On Days -1, 4, 27, and 31

Description: Safety and tolerability will be assessed using variables like AEs/SAEs, vital signs, ECGs, changes in clinical chemistry/haematology parameters, morning serum cortisol, and adrenocorticotropic hormone.

Measure: Safety and tolerability of AZD9567 by assessing the number of participants with adverse events

Time: From screening up to 79 days
26 Evaluation of Physical Activity, Quality of Life and Depression of Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.

NCT04558645
Conditions
  1. Type 1 Diabetes Mellitus
  2. Covid19
Interventions
  1. Other: Online Survey
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 1
HPO:Diabetes mellitus Type I diabetes mellitus

Primary Outcomes

Description: Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.

Measure: Physical activity level

Time: Five minutes

Description: Quality of life using Short Form Health Survey (SF-36) will be evaluated.

Measure: General Quality of life

Time: Ten minutes

Secondary Outcomes

Description: Depression using Hospital Anxiety and Depression Scale will be evaluated.

Measure: Depression

Time: Three minutes

Description: Anxiety using Hospital Anxiety and Depression Scale will be evaluated.

Measure: Anxiety

Time: Three minutes

Description: It will be questioned how many times patients have had hypoglycemic attacks (<4 mmol/L and common symptoms) in the last 7 days.

Measure: Self-reported hypoglycemia

Time: Last seven day

Description: Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.

Measure: Loneliness

Time: Three minutes

Description: Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.

Measure: Hypoglisemia fear

Time: Five minutes

Description: Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.

Measure: Dyspnea

Time: Two minutes
27 Health-related Outcomes and Behaviour Changes in a Cohort of Diabetic Population During COVID-19 Pandemic: Results of a Telephonic Survey

Diabetes management and follow-up has become a challenge during the COVID-19 pandemic. Nation-wide lockdowns and social distancing measures adopted in an attempt to break the chain of COVID-19 transmission have significantly disrupted routine care and follow-up of diabetes. In the health sector, especially in low-income countries such as Pakistan, there has been a shift of resources and staff reassignment from stable chronic illnesses to support COVID-19 pandemic. Disruption of routine outpatient health services and travel restrictions increase the risk of worsening diabetes control and diabetes-related health outcomes. Additionally, social isolation amidst an atmosphere of fear and uncertainty contributes to stress further affecting glycaemic control.

NCT04573335
Conditions
  1. Diabetes
  2. Covid19
  3. Isolation, Social
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: Death due to diabetes-related complications or otherwise

Measure: All-cause mortality

Time: during 3months of lockdown

Secondary Outcomes

Description: %age of participants with one or more symptoms of fever, sore throat, cough, dyspnoea

Measure: COVID-19 illness

Time: During 3months of lockdown
28 A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions. Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh. The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak. Women cannot take part if pregnant, breast- feeding or plan to become pregnant during the study period.

NCT04582448
Conditions
  1. Diabetes Mellitus, Type 2
Interventions
  1. Drug: Insulin icodec
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: pmol*h/L

Measure: AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose

Time: From 0 hours until infinity after trial product administration (Day 1)

Secondary Outcomes

Description: pmol/L

Measure: Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose

Time: From 0 hours until last measurement time after trial product administration (Day 1)

Description: hours

Measure: tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose

Time: From 0 hours until last measurement time after trial product administration (Day 1)
29 Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19

The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.

NCT04591015
Conditions
  1. Diabetes Mellitus, Type 2
  2. Covid19
Interventions
  1. Behavioral: Hospital: DD-CA
  2. Behavioral: Hospital: Usual Care (UC)
MeSH:Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Type II diabetes mellitus

Primary Outcomes

Description: The Electronic Medical Record (EMR) will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 30-day period by a Fisher's exact test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the primary outcome, rate of readmissions within 30-days. We do not anticipate missing data for covariates included in regression models since demographic data will be captured directly from the EMR, and baseline glycemic control (i.e. HbA1c at hospital admission) and COVID-19 diagnosis will be determined during the admission of study enrollment.

Measure: Readmission rate (30-days)

Time: 30-days

Description: Additional metrics of glycemic control will be captured for each study participant from the EMR including HbA1c at 90-days post-discharge. Unadjusted group mean differences in HbA1c will be assessed with a students t-test, followed by multiple linear regression analysis controlling for baseline HbA1c (at time of initial admission), as well as covariates including gender, ethnicity, race, comorbid conditions including COVID-19, and medication/steriod use, in addition to study arm, as fixed effects in predicting HbA1c at 90 days.

Measure: Glycosylated Hemoglobin (HbA1c)

Time: Baseline, 90-days

Secondary Outcomes

Description: Diabetes distress will be measured using the Diabetes Distress Scale (DDS); range 1-6, with higher scores indicating worse outcomes/greater diabetes-related emotional stress. The survey will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.

Measure: Diabetes Distress Scale

Time: Baseline, 90-days

Description: Research assistants will deliver the COVID-19 Patient Survey (PhenixToolkit) to each participant at their 90-day follow up to obtain their COVID-19 diagnosis status to determine whether any new infections occurred in the 90-day post-discharge time frame. Additional questions in the survey will be used for descriptive analyses to characterize infections. Differences in proportions of patients experiencing new infections per group (i.e. patients who were negative at discharge but had a self-reported positive test within 90 days) will be compared by Fisher's exact tests.

Measure: COVID-19 Patient Survey

Time: 90-days

Description: Summary of Diabetes Self-Care Activities (SDSCA; range 0-7, with higher scores indicating better outcomes/greater adherence to diabetes self-management behaviors) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.

Measure: Summary of Diabetes Self-Care Activities Survey

Time: Baseline, 90-days

Description: Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 (range 0-100, with higher scores reflecting better outcomes/higher quality of life) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.

Measure: PROMIS Quality of Life Scale

Time: Baseline, 90-days

Description: Knowledge, Attitudes and Practices Toward COVID-19 Survey (range 0-12, with higher scores reflecting better knowledge of COVID-19) will be administered immediately post enrollment, prior to randomizing, and during the 90-day follow-up visit. Measures will be compared between groups by t-tests at each time point.

Measure: Knowledge, Attitudes and Practice Toward COVID-19 Survey

Time: Baseline, 90-days

Description: Socio-Economic Status (SES), nativity, duration of US residence, Marital status, depressive symptoms and healthcare utilization will be measured immediately post enrollment, prior to randomizing.

Measure: Demographics Questionnaire

Time: Baseline

Other Outcomes

Description: Exploratory analyses will be conducted similarly to our Primary Outcome. The EMR will be used to identify readmissions during each patient's unique follow up period. Unadjusted between group differences will first be analyzed by comparing proportion of patients with any hospital readmissions within the 90-day period by a Fisher's exact t-test. Followup analyses will be conducted using multiple logistic regression models to account for gender, ethnicity, race, comorbid conditions including COVID-19, medication use, and baseline glycemic control, in addition to study arm, as fixed effects in predicting the exploratory outcome, rate of readmissions within 90-days.

Measure: Readmission Rate (90-days)

Time: 90-days
30 The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19

All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.

NCT04591704
Conditions
  1. Covid19
  2. Diabetes Mellitus
Interventions
  1. Other: hospitalisation, necessity of ICU, mortality rate, lung involvement
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: The time between admission to hospital and discharge

Measure: Duration of Hospitalisation

Time: 1 year

Description: The admission of hospitalized patients to the intensive care unit.

Measure: The need for ICU

Time: 1 year

Description: Mortality rates of patients

Measure: Mortality

Time: 1 year

Description: The presence of lung involvement on thorax CT

Measure: Lung involvement

Time: 1 year
31 The Effect of COVID-19 on the Glycemic Control in Patients With Diabetes Mellitus

The study aimed to evaluate the effect of SARS-COV-2 infection on metabolic status in patients with diabetes mellitus. Patients' HbA1c levels before and after SARS-COV-2 infection will be evaluated.

NCT04592055
Conditions
  1. Diabetes Mellitus
  2. Covid19
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: the change in A1c levels

Measure: A1c

Time: 6 months (3 months before and after COVID-19
32 Technology-enabled Collaborative Care for Diabetes (TECC-Diabetes) Management During COVID: A Feasibility Study

The overall goal of this research program is to evaluate the effectiveness of a Technology-Enabled Collaborative Care program. In this study, we examine the feasibility of such a program, called the Technology-Enabled Collaborative Care (TECC) for type 2 diabetes designed to support patients with diabetes and mental health concerns during COVID-19.

NCT04607915
Conditions
  1. Type 2 Diabetes
Interventions
  1. Behavioral: Intervention for TECC Model
MeSH:Diabetes Mellitus
HPO:Diabetes mellitus

Primary Outcomes

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes assessing recruitment number

Measure: Feasibility - Recruitment Numbers

Time: Through the study completion, an average of 4 months

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes participant characteristics

Measure: Feasibility - Participant characteristics

Time: up to 8-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes participant retention rate (e.g., defined by time between first and last visit)

Measure: Feasibility - Participant Engagement (retention rate)

Time: up to 8-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes intensity (e.g., number of session participants attend)

Measure: Feasibility - Participant Engagement (intensity)

Time: up to 8-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes drop out (consented/enrolled but did not attend first one-on-one)

Measure: Feasibility - Participant Engagement (drop out)

Time: up to 8-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes the amount of time a coach spends per interaction

Measure: Feasibility - Delivery of Intervention (Time with coach)

Time: up to 8-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes the mode of the interaction (i.e., virtual, telephone or both)

Measure: Feasibility - Delivery of Intervention (Mode of interaction)

Time: up to 12-weeks

Description: The primary outcome in this study is feasibility, specifically process outcomes. This includes what strategies are used by the coach (i.e., educational, psychosocial support, behaviour modifications, or case management/monitoring)

Measure: Feasibility - Delivery of Intervention (Coach strategies)

Time: up to 12-weeks

Secondary Outcomes

Description: The secondary outcome consists of study participant experience/satisfaction.

Measure: Study Participant experience and satisfaction via semi-structured interview

Time: up to 8-weeks

Description: The secondary outcome consists of Care Coordinator experience and satisfaction.

Measure: Care Coordinator experience and satisfaction via semi-structured interview

Time: up to 8-weeks

Description: The secondary outcome consists of Virtual Care Team experience and satisfaction.

Measure: Virtual Care Team experience and satisfaction via semi-structured interview

Time: up to 8-weeks

Other Outcomes

Description: The exploratory outcomes will include Health Behaviour metrics via International Physical Activity Questionnaire). Individual scores per question, the higher the score means the higher the level of physical activity.

Measure: Exploratory Outcome - Health Behaviour metrics (physical activity)

Time: up to 4-weeks

Description: The exploratory outcomes will include Health Behaviour metrics (via Mediterranean Diet Adherence Screener Modified (MEDAS modified)

Measure: Exploratory Outcome - Health Behaviour metrics (diet)

Time: up to 4-weeks

Description: The exploratory outcomes will include Health Behaviour metrics (via readiness to change ruler (smoking, alcohol, nutrition, physical activity). Minimum score: 0; maximum score: 10; higher score represented a better outcome.

Measure: Exploratory Outcome - Health Behaviour metrics (confidence/importance to change behaviour)

Time: up to 12-weeks

Description: The exploratory outcomes will include substance use (via GAINS-SS (Global Appraisal of Individual Needs- Short Screener). Minimum score: 0; maximum score: 20; higher score represented a worse outcome.

Measure: Exploratory Outcome - Substance Use (GAINS-SS)

Time: up to 12-weeks

Description: The exploratory outcomes will include substance use (Alcohol Use Disorders Identification Test (AUDIT); Minimum score: 0; maximum score: 40; higher score represented a worse outcome.

Measure: Exploratory Outcome - Substance Use (alcohol)

Time: up to 12-weeks

Description: The exploratory outcomes will include substance use (via heaviness of smoking index - 2 items out of Fagerstrom test for nicotine dependence (FTND)); Minimum score: 0; maximum score: 6; higher score represented a worse outcome.

Measure: Exploratory Outcome - Substance Use

Time: up to 12-weeks

Description: The exploratory outcomes will include Mental Health measures (via Patient Health Questionnaire (PHQ-9)). Minimum score: 0; maximum score: 27; higher score represented a worse outcome.

Measure: Exploratory Outcome - Mental Health (depression)

Time: up to 12-weeks

Description: The exploratory outcomes will include Mental Health measures via Generalized Anxiety Disorder-7 (GAD-7). Minimum score: 0; maximum score: 21; higher score represented a worse outcome.

Measure: Exploratory Outcome - Mental Health (Anxiety)

Time: up to 12-weeks

Description: The exploratory outcomes will include Mental Health measures via Diabetes awareness and insight scale. Minimum score: 0; maximum score: 10; higher score represented a better outcome.

Measure: Exploratory Outcome - Mental Health (Diabetes awareness/insight)

Time: up to 12-weeks

Description: The exploratory outcomes will include Mental Health measures via Diabetes Distress Scale. Minimum score: 0; maximum score: 6; higher score represented a worse outcome.

Measure: Exploratory Outcome - Mental Health (Diabetes Distress)

Time: up to 12-weeks

Description: The exploratory outcomes will include Mental Health measures via perceived stress scale (PSS). Minimum score: 0; maximum score: 40; higher score represented a worse outcome (i.e., higher perceived stress).

Measure: Exploratory Outcome - Mental Health (Stress)

Time: up to 12-weeks

Description: The exploratory outcomes will include quality of life (via European Quality of Life - 5 Dimensions scale - EQ5D). Minimum score: 0; maximum score: 100; higher score represented a better outcome.

Measure: Exploratory Outcome - Quality of Life

Time: up to 12-weeks

Description: The exploratory outcomes will include quality of life (via Verona satisfaction scale). Minimum score: 0; higher score represented a better outcome.

Measure: Exploratory Outcome - Quality of Life

Time: up to 12-weeks

Description: self-report

Measure: Exploratory Outcome - Waist circumference

Time: up to 12-weeks

Description: self-report

Measure: Exploratory Outcome - BMI (height/weight)

Time: up to 12-weeks

Description: self-report

Measure: Exploratory Outcome - Blood pressure

Time: up to 12-weeks

Description: list

Measure: Exploratory Outcome - Current medication

Time: up to 12-weeks

Description: Hemoglobin A1C levels

Measure: Exploratory Outcome - Blood work

Time: up to 12-weeks

Description: Brief Pain Inventory-sf. Minimum score: 0; maximum score: 10; higher score represented a worse outcome (i.e., more pain).

Measure: Exploratory Outcome - Pain

Time: up to 12-weeks

Description: months

Measure: Exploratory Outcome - Diabetes duration

Time: up to 12-weeks

Description: Diabetes Self-Management and Technology Questionnaire (DSMT-Q); Minimum score: 0; maximum score: 48; higher score represented a worse outcome.

Measure: Exploratory Outcome - Diabetes self-management

Time: up to 12-weeks
33 OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT RENAL IMPAIRMENT

This study will characterize the effect of varying degrees of renal impairment on the pharmacokinetics (PK), safety and tolerability of a single oral dose of PF- 06882961 compared with participants with normal renal function.

NCT04616027
Conditions
  1. Diabetes Mellitus, Type 2
  2. Renal Impairment
  3. Healthy
Interventions
  1. Drug: PF-06882961 20 mg
MeSH:Renal Insuffici Renal Insufficiency Diabetes Mellitus Diabetes Mellitus, Type 2
HPO:Diabetes mellitus Renal insufficiency Type II diabetes mellitus

Primary Outcomes

Measure: Maximum plasma concentration [C(max)]

Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

Measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(inf)]

Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

Measure: Area under the plasma concentration-time [AUC(last)]

Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

Measure: Fraction of unbound drug in plasma [fu]

Time: Hour 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 on Day 1, Hour 24 and 36 on Day 2, Hour 48 on Day 3

Secondary Outcomes

Measure: Unbound Maximum Observed Plasma Concentration [C(max,u)]

Time: Hour 0 and 4 on Day 1

Measure: Unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(inf,u)]

Time: Hour 0 and 4 on Day 1

Measure: Unbound area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration [AUC[last,u])

Time: Hour 0 and 4 on Day 1

Measure: Apparent Oral Clearance [CL/F]

Time: Hour 0 and 4 on Day 1

Measure: Apparent clearance of unbound drug [CL(u)/F]

Time: Hour 0 and 4 on Day 1

Measure: Apparent volume of distribution [V(z)/F]

Time: Hour 0 and 4 on Day 1

Measure: Time to Reach Maximum Observed Plasma Concentration [T(max)]

Time: Hour 0 and 4 on Day 1

Measure: Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].

Time: Hour 0 and 4 on Day 1

Measure: Incidence and severity of treatment emergent adverse events (AEs and SAEs)

Time: Baseline through Day 28

Measure: Incidence of treatment emergent clinical laboratory abnormalities

Time: Baseline to Day 3

Measure: Incidence of treatment emergent vital signs

Time: Baseline, Day 1 and Day 3

Measure: Incidence of treatment emergent Electrocardiogram [ECG] abnormalities

Time: Baseline, Day 1 and Day 3

HPO Nodes


HP:0000819: Diabetes mellitus
Genes 547
VANGL2 NR2E3 WFS1 GLIS3 FOXH1 PROK2 TRNL1 NDUFS6 PPARG PEX1 FBN1 LMNB2 LIMK1 PRPF4 RP2 CFTR PAX4 PPARG CTNNB1 HBB COL2A1 POC1A KCTD1 LIG4 PDE6B TOPORS ARL2BP ABCC8 SLC30A8 KCNJ11 MLXIPL CDON WRN PRKAR1A PROM1 TRNE NEUROD1 CNBP KCNJ11 MMP14 C8ORF37 APOE SLC16A2 CTRC ZBTB20 BBS2 WFS1 BLK WFS1 KRAS COX3 CYTB ZFYVE26 FGF8 SOX2 XRCC4 CDH23 ELN CEL GPR35 SLC29A3 FOXC2 EIF2AK3 PTF1A TCF7L2 HNF1A ARMC5 MKKS PDE6A PDX1 COX2 PSTPIP1 EIF2AK3 GTF2I NEUROD1 CNOT1 ATP6 USH2A ITPR3 LMNA NDUFA1 NDUFA11 CAVIN1 PCARE HLA-DRB1 CAT TCF4 AIP GCK PLCD1 HNF4A HERC2 PDX1 OTX2 HJV TRNH IL6 PWAR1 PAX4 TKT RPE65 REEP6 HNF4A RLBP1 SIX3 CFTR IGF2BP2 HNF1A POMGNT1 ND1 SAG GCK BLK GPD2 RAC1 AKT2 SEMA4A WRAP53 MOG CP ARL6 AIP ALMS1 SBDS NPAP1 CDHR1 ITCH BLM HNF1B NSMCE2 ARNT2 TWNK PDX1 PDX1 DLL1 ROM1 NDUFAF3 SNORD116-1 PDE11A NDUFS4 FOXP3 WRN ZMPSTE24 UBR1 ZNF513 INSR IARS1 SLC19A2 RP1 GJA1 TRNS2 TRNS1 PRKACA PCNT FLT1 NOTCH3 TULP1 LMNA MC4R PRKACA PNPLA6 CAV1 IFIH1 NOP10 NEUROD1 MEN1 PLAGL1 ND3 TRNK ZFP57 BRCA2 SPATA7 OPA1 VANGL1 DMXL2 NODAL GJB4 EDA2R HBB CA4 MKRN3 SNORD115-1 FXN GATA6 WFS1 RP9 ND4 TMEM126B NDP BRCA1 SLC19A2 ND5 HMGA1 NDUFAF1 MERTK RETN PRPF6 HLA-DQB1 SPINK1 CP COX1 HNF4A RPGR ND6 MST1 GUCA1B NDUFA6 EDA HNF1A RNASEH2C ALMS1 TIMMDC1 HFE CIDEC DNAJC3 INS KIAA1549 IRS1 LMNA PROKR2 GCK PRKAR1A HNF1B LEPR POLR3A HYMAI SNRNP200 LIPE HYMAI CNGB1 CLRN1 ZIC2 APOA5 GAS1 EFL1 PIK3R1 TTC8 SARS2 HNF1A GJA1 PTF1A RNASEH2B TRNF NEUROG3 LRP6 TDGF1 NDUFB11 HESX1 NDN FOXP3 HNF1B ABCC8 ND2 TGIF1 PRPH2 DNM1L PRSS2 BBS2 INS NUBPL LIPE SAMHD1 DISP1 DHDDS LEMD3 DKC1 MKRN3-AS1 KLF11 IDH3B TRNL1 GLI2 FUZ SMPD4 COX1 PLIN1 SLC25A4 CNGA1 LHX1 SNRPN INS AGPAT2 GNAS SUFU DNAJC21 FOS SPINK1 CAV1 ARL3 HFE TUB TRNK KLF11 AKT2 NDUFB3 PPP1R3A NEK2 STAT1 PRPF3 RDH12 USP8 IFT172 BSCL2 ABCC8 HAMP PDE8B NDUFV1 PNPLA2 CYP19A1 LMNA ARHGEF18 MMP2 ABCA4 LRAT NDUFS7 INS TRNL1 LMNA ABCC8 PAX4 PRSS1 CLIP2 BEST1 SCAPER PIK3R1 ZNF408 SIM1 KCNJ11 PTRH2 FXN TRMT10A CASR BAZ1B ATM CPA1 NDUFS2 BRAF ADAR ZFP57 APPL1 TRNQ TRNQ RRM2B DNAJC3 STOX1 RFC2 PRCD DHX38 HNF1B IRS2 SMAD4 HNF1A ND1 KCNJ11 SLC7A14 PDE4D CDKN2A IL18BP PTRH2 NDUFS3 TRNF NDUFAF2 FAM161A VANGL2 FGFR1 CISD2 ABCC8 LEP XRCC4 TTPA NHP2 NKX2-5 AMACR MAGEL2 KDSR POLD1 KIZ INS CORIN NDUFS8 DCAF17 NDUFAF4 FOXRED1 PEX6 COX3 PRSS2 MTNR1B BMP2 PEX10 PARN PAX4 NDUFB10 ND1 INSR PRSS1 TP53 NPM1 MAGEL2 HBB POLG2 SOX3 SLC12A3 AIRE UBR1 GCK IL2RA TRNW WFS1 IMPG2 TRNS2 PTCH1 LEPR KCNJ11 IL2RA CLCNKB ATM STAT3 AGBL5 CARS1 HMGA2 COX2 MAFA TTC7A TWNK GJB3 LMNA AHR PLAGL1 PALLD NDUFS1 CRX CRB1 GATA6 GLRX5 ENPP1 CEL HNF4A CTC1 TRNV RNASEH2A HYMAI NDUFV2 IMPDH1 APPL1 BBS1 PALB2 GTF2IRD1 EIF2S3 SHH AEBP1 SLC2A2 PRPF31 MTHFR KLHL7 NDUFAF8 TERC PDX1 GCK TP53 AGPAT2 CCDC28B SLC29A3 ABCC8 PLIN1 GATA3 NRL PDE6G RBP3 PDX1 DCAF17 IPW NDUFAF5 MTHFR XRCC4 CTNS GCK FGFR1 STUB1 HNF1A BLM ELMO2 STAT3 HGSNAT KCNJ11 CERKL TRNW RTEL1 TRNC CTRC KCNJ11 RHO IDH3A RP1L1 TREX1 ITCH PNPLA2 PWRN1 CNOT1 FOXP1 ND6 EYS SRP54 TINF2 INSR IFT88 POLG ARL6 AHI1 ELN PTPN22 CEP19 PRPF8 POLA1 MAPK8IP1 MAK ND5 TERT LIPC BSCL2 AR CISD2 KCNJ11 OFD1 USB1 TBL2 RGR ERGIC1 FSCN2 NDUFB9 IER3IP1 INS DMPK PTPN1 NSMCE2 GPR101 HNF4A PPARG IFT140 PPARG PDE4D GCK TRNS1 SPINK1 PPP1R15B ABCC8 STAT1 IGF1R TRNE

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


HP:0000819: Diabetes mellitus
Genes 547
VANGL2 NR2E3 WFS1 GLIS3 FOXH1 PROK2 TRNL1 NDUFS6 PPARG PEX1 FBN1 LMNB2 LIMK1 PRPF4 RP2 CFTR PAX4 PPARG CTNNB1 HBB COL2A1 POC1A KCTD1 LIG4 PDE6B TOPORS ARL2BP ABCC8 SLC30A8 KCNJ11 MLXIPL CDON WRN PRKAR1A PROM1 TRNE NEUROD1 CNBP KCNJ11 MMP14 C8ORF37 APOE SLC16A2 CTRC ZBTB20 BBS2 WFS1 BLK WFS1 KRAS COX3 CYTB ZFYVE26 FGF8 SOX2 XRCC4 CDH23 ELN CEL GPR35 SLC29A3 FOXC2 EIF2AK3 PTF1A TCF7L2 HNF1A ARMC5 MKKS PDE6A PDX1 COX2 PSTPIP1 EIF2AK3 GTF2I NEUROD1 CNOT1 ATP6 USH2A ITPR3 LMNA NDUFA1 NDUFA11 CAVIN1 PCARE HLA-DRB1 CAT TCF4 AIP GCK PLCD1 HNF4A HERC2 PDX1 OTX2 HJV TRNH IL6 PWAR1 PAX4 TKT RPE65 REEP6 HNF4A RLBP1 SIX3 CFTR IGF2BP2 HNF1A POMGNT1 ND1 SAG GCK BLK GPD2 RAC1 AKT2 SEMA4A WRAP53 MOG CP ARL6 AIP ALMS1 SBDS NPAP1 CDHR1 ITCH BLM HNF1B NSMCE2 ARNT2 TWNK PDX1 PDX1 DLL1 ROM1 NDUFAF3 SNORD116-1 PDE11A NDUFS4 FOXP3 WRN ZMPSTE24 UBR1 ZNF513 INSR IARS1 SLC19A2 RP1 GJA1 TRNS2 TRNS1 PRKACA PCNT FLT1 NOTCH3 TULP1 LMNA MC4R PRKACA PNPLA6 CAV1 IFIH1 NOP10 NEUROD1 MEN1 PLAGL1 ND3 TRNK ZFP57 BRCA2 SPATA7 OPA1 VANGL1 DMXL2 NODAL GJB4 EDA2R HBB CA4 MKRN3 SNORD115-1 FXN GATA6 WFS1 RP9 ND4 TMEM126B NDP BRCA1 SLC19A2 ND5 HMGA1 NDUFAF1 MERTK RETN PRPF6 HLA-DQB1 SPINK1 CP COX1 HNF4A RPGR ND6 MST1 GUCA1B NDUFA6 EDA HNF1A RNASEH2C ALMS1 TIMMDC1 HFE CIDEC DNAJC3 INS KIAA1549 IRS1 LMNA PROKR2 GCK PRKAR1A HNF1B LEPR POLR3A HYMAI SNRNP200 LIPE HYMAI CNGB1 CLRN1 ZIC2 APOA5 GAS1 EFL1 PIK3R1 TTC8 SARS2 HNF1A GJA1 PTF1A RNASEH2B TRNF NEUROG3 LRP6 TDGF1 NDUFB11 HESX1 NDN FOXP3 HNF1B ABCC8 ND2 TGIF1 PRPH2 DNM1L PRSS2 BBS2 INS NUBPL LIPE SAMHD1 DISP1 DHDDS LEMD3 DKC1 MKRN3-AS1 KLF11 IDH3B TRNL1 GLI2 FUZ SMPD4 COX1 PLIN1 SLC25A4 CNGA1 LHX1 SNRPN INS AGPAT2 GNAS SUFU DNAJC21 FOS SPINK1 CAV1 ARL3 HFE TUB TRNK KLF11 AKT2 NDUFB3 PPP1R3A NEK2 STAT1 PRPF3 RDH12 USP8 IFT172 BSCL2 ABCC8 HAMP PDE8B NDUFV1 PNPLA2 CYP19A1 LMNA ARHGEF18 MMP2 ABCA4 LRAT NDUFS7 INS TRNL1 LMNA ABCC8 PAX4 PRSS1 CLIP2 BEST1 SCAPER PIK3R1 ZNF408 SIM1 KCNJ11 PTRH2 FXN TRMT10A CASR BAZ1B ATM CPA1 NDUFS2 BRAF ADAR ZFP57 APPL1 TRNQ TRNQ RRM2B DNAJC3 STOX1 RFC2 PRCD DHX38 HNF1B IRS2 SMAD4 HNF1A ND1 KCNJ11 SLC7A14 PDE4D CDKN2A IL18BP PTRH2 NDUFS3 TRNF NDUFAF2 FAM161A VANGL2 FGFR1 CISD2 ABCC8 LEP XRCC4 TTPA NHP2 NKX2-5 AMACR MAGEL2 KDSR POLD1 KIZ INS CORIN NDUFS8 DCAF17 NDUFAF4 FOXRED1 PEX6 COX3 PRSS2 MTNR1B BMP2 PEX10 PARN PAX4 NDUFB10 ND1 INSR PRSS1 TP53 NPM1 MAGEL2 HBB POLG2 SOX3 SLC12A3 AIRE UBR1 GCK IL2RA TRNW WFS1 IMPG2 TRNS2 PTCH1 LEPR KCNJ11 IL2RA CLCNKB ATM STAT3 AGBL5 CARS1 HMGA2 COX2 MAFA TTC7A TWNK GJB3 LMNA AHR PLAGL1 PALLD NDUFS1 CRX CRB1 GATA6 GLRX5 ENPP1 CEL HNF4A CTC1 TRNV RNASEH2A HYMAI NDUFV2 IMPDH1 APPL1 BBS1 PALB2 GTF2IRD1 EIF2S3 SHH AEBP1 SLC2A2 PRPF31 MTHFR KLHL7 NDUFAF8 TERC PDX1 GCK TP53 AGPAT2 CCDC28B SLC29A3 ABCC8 PLIN1 GATA3 NRL PDE6G RBP3 PDX1 DCAF17 IPW NDUFAF5 MTHFR XRCC4 CTNS GCK FGFR1 STUB1 HNF1A BLM ELMO2 STAT3 HGSNAT KCNJ11 CERKL TRNW RTEL1 TRNC CTRC KCNJ11 RHO IDH3A RP1L1 TREX1 ITCH PNPLA2 PWRN1 CNOT1 FOXP1 ND6 EYS SRP54 TINF2 INSR IFT88 POLG ARL6 AHI1 ELN PTPN22 CEP19 PRPF8 POLA1 MAPK8IP1 MAK ND5 TERT LIPC BSCL2 AR CISD2 KCNJ11 OFD1 USB1 TBL2 RGR ERGIC1 FSCN2 NDUFB9 IER3IP1 INS DMPK PTPN1 NSMCE2 GPR101 HNF4A PPARG IFT140 PPARG PDE4D GCK TRNS1 SPINK1 PPP1R15B ABCC8 STAT1 IGF1R TRNE

Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

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