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Sections: Correlations,
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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug141 | AZD9567 Wiki | 0.20 |
| drug1899 | Low-Carbohydrate Diet Wiki | 0.20 |
| drug1840 | Linagliptin 5 MG Wiki | 0.20 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1580 | Hypocaloric, low carbohydrate diet Wiki | 0.20 |
| drug2000 | Mediterranean diet, no caloric restriction Wiki | 0.20 |
| drug3295 | Supported Adopted Intervention 2 Wiki | 0.20 |
| drug1581 | Hypocaloric, moderate low fat diet Wiki | 0.20 |
| drug2641 | PreserVision AREDS formulation gel tabs Wiki | 0.20 |
| drug3682 | Viusid and Asbrip Wiki | 0.20 |
| drug3225 | Standard of Care (SOC) and Colchicine+Rosuvastatin Wiki | 0.20 |
| drug3996 | no interventional study Wiki | 0.20 |
| drug339 | Attention Control Intervention 4 Wiki | 0.20 |
| drug3294 | Supported Adopted Intervention 1 Wiki | 0.20 |
| drug3574 | Ultrasound of the lower limbs Wiki | 0.20 |
| drug1404 | Glycaemic levels Wiki | 0.20 |
| drug2739 | Quercetin Treatment Wiki | 0.20 |
| drug1682 | Interactive workshops LiPAT intervention group Wiki | 0.20 |
| drug257 | Anti-Human Thymocyte Immunoglobulin, Rabbit Wiki | 0.20 |
| drug748 | Centrum Adult (under 50) multivitamin Wiki | 0.20 |
| drug3361 | TOF protocol Wiki | 0.20 |
| drug3729 | Wrist-worn feedback physical activity monitor Wiki | 0.20 |
| drug1877 | Lovenox 40 MG in 0.4 mL Prefilled Syringe Wiki | 0.20 |
| drug1034 | Dexcom G6 Wiki | 0.20 |
| drug2502 | Pioglitazone 30 mg Wiki | 0.20 |
| drug596 | CFZ533 Wiki | 0.20 |
| drug3296 | Supported Adopted Intervention 3 Wiki | 0.20 |
| drug3786 | antidiabetic treatment Wiki | 0.20 |
| drug3399 | Telephone Coaching Wiki | 0.20 |
| drug2448 | Patients with the treatment agains COVID19 Wiki | 0.20 |
| drug3728 | Workshops control group LiPAT Wiki | 0.20 |
| drug3150 | Smartphone application LiPAT Wiki | 0.20 |
| drug3715 | Weight Counseling Wiki | 0.20 |
| drug1918 | MANAGEMENT OF COVID-19 Wiki | 0.20 |
| drug1835 | Lifestyle App Wiki | 0.20 |
| drug3385 | Tele-interventions related to diabetes management and mental well-being Wiki | 0.20 |
| drug2738 | Quercetin Prophylaxis Wiki | 0.20 |
| drug2631 | Prednisolone Wiki | 0.20 |
| drug719 | Canakinumab Wiki | 0.14 |
| drug4118 | standard of care Wiki | 0.12 |
| drug3395 | Telemedicine Wiki | 0.10 |
| drug2327 | Online Survey Wiki | 0.09 |
| drug3993 | no intervention Wiki | 0.07 |
| drug2505 | Placebo Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.52 |
| D003922 | Diabetes Mellitus, Type 1 NIH | 0.51 |
| D008659 | Metabolic Diseases NIH | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D044882 | Glucose Metabolism Disorders NIH | 0.35 |
| D004700 | Endocrine System Diseases NIH | 0.28 |
| D006943 | Hyperglycemia NIH | 0.14 |
| D018149 | Glucose Intolerance NIH | 0.12 |
| D011236 | Prediabetic State NIH | 0.10 |
| D001835 | Body Weight NIH | 0.10 |
| D000073496 | Frailty NIH | 0.08 |
| D050177 | Overweight NIH | 0.08 |
| D008107 | Liver Diseases NIH | 0.07 |
| D012140 | Respiratory Tract Diseases NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000819 | Diabetes mellitus HPO | 0.87 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.44 |
| HP:0100651 | Type I diabetes mellitus HPO | 0.38 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000818 | Abnormality of the endocrine system HPO | 0.28 |
| HP:0011998 | Postprandial hyperglycemia HPO | 0.20 |
| HP:0001392 | Abnormality of the liver HPO | 0.07 |
Navigate: Correlations HPO
There are 25 clinical trials
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.
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 yearsDescription: 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 yearsDescription: Incidence of hospitalization will be assessed for COVID-19 positive patients
Measure: Hospitalization Time: 1 yearDescription: Incidence of intubation will be assessed for COVID-19 positive patients
Measure: Intubation Time: 1 yearDescription: Incidence of death will be assessed for COVID-19 positive patients
Measure: Death Time: 1 yearPatient-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.
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 upIn 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.
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.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).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.
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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitDescription: 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) VisitThe 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.
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 monthsThe 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.
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 monthsDescription: 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 monthsDescription: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at day 1Description: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at 1 weekDescription: To evaluate the pharmacokinetics (PK) of CFZ533.
Measure: Free CFZ533 plasma concentration. Time: at 12 monthsDescription: To evaluate the treatment effect of CFZ533 on full or partial remission.
Measure: Proportion of subjects with full or partial remission. Time: at 12 monthsDescription: To evaluate durability of effects of CFZ533 on pancreatic beta cell function.
Measure: Stimulated C-peptide AUC by MMTT. Time: at 3 yearsSedentary 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.
Description: peak volume of oxygen consumption (VO2 peak) in ml/kg/min measured via graded exercise test
Measure: cardiorespiratory fitness Time: 8-12 minutesDescription: glucose infusion rate in mg/kg/min as measured via hyperinsulinemic-euglycemic clamp
Measure: insulin sensitivity Time: 3 hoursCOVID-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.
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 monthDescription: 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 monthDescription: 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 monthDescription: 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 monthINTRODUCTION 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.
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)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)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.
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 daysDescription: 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 daysThis 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.
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 daysDescription: 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 daysDescription: Differences in the number of patients who received complementary medications for diagnosis between the study arms.
Measure: Complementary drugs required Time: 21 daysDescription: Differences in the number of patients in the study groups experiencing side effects of the supplements.
Measure: Side effects of supplementation Time: 21 daysDescription: 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 daysDescription: Blood biochemical analysis at day 0, 3rd, 7th, 14th and 21th
Measure: Concentration of reactive protein c in peripheral blood Time: 21 daysDescription: Number of Incidence of hospitalization
Measure: Incidence of hospitalization Time: 21 daysDescription: Number of days of hospitalization
Measure: Duration (days) of hospitalization Time: 21 daysDescription: Number of Incidences of mechanical ventilation supply per patient
Measure: Incidence of mechanical ventilation supply Time: 21 daysDescription: Number of days with mechanical ventilation supply
Measure: Duration (days) of mechanical ventilation supply Time: 21 daysDescription: Number of incidences of oxygen use
Measure: Incidence of oxygen use Time: 21 daysDescription: Number of days of oxygen use per patient
Measure: Duration (days) of oxygen use Time: 21 daysDescription: Number of death per group
Measure: Mortality rate Time: 21 daysDescription: Number of days patient need to recover from disease
Measure: Time to return to normal activity Time: 21 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: 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 daysDescription: Change in myocardial enzymes troponins by blood biochemical analysis at daty 0, 4, 7, 14 and 21
Measure: Change in myocardial enzymes Time: 21 daysThe 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.
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).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 admissionDescription: 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 admissionDescription: 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)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?
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 monthsDescription: Describe the clinical and biological characteristics of hospitalized subjects with diabetes and COVID-19
Measure: Diabetes-related factors risk Time: 3 monthsThis 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.
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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: Number of techincal errors during the sensors lifetime.
Measure: CGM sensor performance Time: 1-2 weeksDescription: 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 weeksThe 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.
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 monthsDescription: Change in HbA1c measured over the study period
Measure: Glycated hemoglobin (HbA1c) Time: Baseline to 6 monthsDescription: 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 monthsDescription: 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 monthsThe 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.
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 lockdownDescription: 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 lockdownDescription: 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 lockdownDescription: 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 lockdownDescription: 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 lockdownDescription: 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 lockdownDescription: 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 lockdownDescription: 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 lockdownThe 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.
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 periodDescription: 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 periodDescription: 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 periodA 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
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).
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 placeboDescription: 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 weeksDescription: Death rate during the 4-week period after study treatment
Measure: Death rate Time: 4 weeksDescription: 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 weeksDescription: 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 weeksDescription: Prolonged hospital stay > 3 weeks
Measure: Prolonged hospital stay Time: >3 weeksDescription: Ratio to baseline in the glycated hemoglobin
Measure: Change in ratio to baseline in the glycated hemoglobin Time: Baseline, Day 29 and Day 90Description: Ratio to baseline in the fasting glucose
Measure: Change in ratio to baseline in the fasting glucose Time: Baseline, Day 29Description: Ratio to baseline in the fasting insulin
Measure: Change in ratio to baseline in the fasting insulin Time: Baseline, Day 29Description: Ratio to baseline in the fasting c-peptide
Measure: Change in ratio to baseline in the fasting c-peptide Time: Baseline, Day 29Description: 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 90Description: Ratio to baseline in the D-dimer
Measure: Change in ratio to baseline in the D-dimer Time: Baseline, Day 29Description: 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 90Description: 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 90Description: Type of antidiabetic treatment at Day 29
Measure: Type of antidiabetic treatment at Day 29 Time: Day 29Description: Number of antidiabetic treatment at Day 29
Measure: Number of antidiabetic treatment at Day 29 Time: Day 29Description: Type of antidiabetic treatment at three months
Measure: Type of antidiabetic treatment at three months Time: Month 3Description: Number of antidiabetic treatment at three months
Measure: Number of antidiabetic treatment at three months Time: Month 3During 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.
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 weeksDescription: 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 weeksThe 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.
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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeDescription: 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 dischargeAlthough 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.
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 monthsDescription: Acute phase reactants
Measure: Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthsDescription: Intensive care admission
Measure: Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. Time: 4 monthDescription: 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 monthsDescription: 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 monthPatients 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.
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, 2020Description: 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, 2020Description: 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, 2020Description: 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, 2020Description: 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, 2020Description: 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, 2020Description: 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, 2020The 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.
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 31Description: 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 30Description: 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, 30Description: 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 31Description: 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 31Description: 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 31Description: 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 31Description: The concentration of potassium in urine will be measured over 24 hours.
Measure: 24-hour potassium concentration Time: On Days -1, 3, 27 and 30Description: The concentration of sodium in urine will be measured over 24 hours.
Measure: 24-hour sodium concentration Time: On Days -1, 3, 27 and 30Description: 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 hoursDescription: 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 31Description: 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 31Description: 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 31Description: 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 31Description: 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 daysDuring 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.
Description: Physical activity level using International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be evaluated.
Measure: Physical activity level Time: Five minutesDescription: Quality of life using Short Form Health Survey (SF-36) will be evaluated.
Measure: General Quality of life Time: Ten minutesDescription: Depression using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Depression Time: Three minutesDescription: Anxiety using Hospital Anxiety and Depression Scale will be evaluated.
Measure: Anxiety Time: Three minutesDescription: 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 dayDescription: Loneliness using UCLA Loneliness Scale Short Form (ULS-8) will be evaluated.
Measure: Loneliness Time: Three minutesDescription: Hypoglisemia fear using Hypoglisemia Fear Survey (HFS) will be evaluated.
Measure: Hypoglisemia fear Time: Five minutesDescription: Dyspnea during daily life activites using Modified Medical Research Dyspnea Scale will be evaluated.
Measure: Dyspnea Time: Two minutesAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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