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D003924: Diabetes Mellitus, Type 2

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 (22)


Name (Synonyms) Correlation
drug141 AZD9567 Wiki 0.29
drug1840 Linagliptin 5 MG Wiki 0.29
drug3704 Wearable Activity Trackers, Exercise Prescription and Virtual Care Wiki 0.29
Name (Synonyms) Correlation
drug1404 Glycaemic levels Wiki 0.29
drug1682 Interactive workshops LiPAT intervention group Wiki 0.29
drug3361 TOF protocol Wiki 0.29
drug3729 Wrist-worn feedback physical activity monitor Wiki 0.29
drug1681 Insulin regimen Wiki 0.29
drug2502 Pioglitazone 30 mg Wiki 0.29
drug3141 Sitagliptin Wiki 0.29
drug3786 antidiabetic treatment Wiki 0.29
drug3399 Telephone Coaching Wiki 0.29
drug2448 Patients with the treatment agains COVID19 Wiki 0.29
drug1839 Linagliptin Wiki 0.29
drug3728 Workshops control group LiPAT Wiki 0.29
drug3150 Smartphone application LiPAT Wiki 0.29
drug2136 NO intervention planned due to the observational study design - only a diagnostic testing Wiki 0.29
drug3385 Tele-interventions related to diabetes management and mental well-being Wiki 0.29
drug2631 Prednisolone Wiki 0.29
drug719 Canakinumab Wiki 0.20
drug4118 standard of care Wiki 0.17
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (8)


Name (Synonyms) Correlation
D003920 Diabetes Mellitus, NIH 0.52
D004700 Endocrine System Diseases NIH 0.20
D003922 Diabetes Mellitus, Type 1 NIH 0.18
Name (Synonyms) Correlation
D008659 Metabolic Diseases NIH 0.17
D044882 Glucose Metabolism Disorders NIH 0.17
D012140 Respiratory Tract Diseases NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0005978 Type II diabetes mellitus HPO 0.91
HP:0000819 Diabetes mellitus HPO 0.46
HP:0100651 Type I diabetes mellitus HPO 0.22
Name (Synonyms) Correlation
HP:0000818 Abnormality of the endocrine system HPO 0.20

Clinical Trials

Navigate: Correlations   HPO

There are 12 clinical trials


1 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 Disease
  10. 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).
2 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
3 Effects of DPP4 Inhibition on COVID-19 Patients With Type 2 Diabetes

The purpose of this research is to see if the DPP4 inhibitor linagliptin, an oral medication commonly used to treat type 2 diabetes,can help with diabetes control and reduce the severity of the COVID-19 infection

NCT04341935
Conditions
  1. Coronavirus Infection
  2. Type 2 Diabetes
Interventions
  1. Drug: Linagliptin
  2. Drug: Insulin regimen
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus, Type 2
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Change in glucose control will be assessed via glucose levels obtained from blood serum samples

Measure: Changes in Glucose Llevels

Time: Baseline, up to 2 weeks

Secondary Outcomes

Description: changes in SpO2 will be measured with a Pulseimetry, an indirect, non-invasive method

Measure: Changes in SpO2 levels

Time: Baseline, up to 2 weeks

Description: Changes in IL 6 will be assessed from blood serum samples

Measure: Changes in Interleukin 6 (IL6)

Time: Baseline, up to 2 weeks

Description: Changes in Chest radiography (X-ray)

Measure: Changes in chest structures

Time: Baseline, up to 2 weeks
4 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)
5 The Effect of Sitagliptin Treatment in COVID-19 Positive Diabetic Patients

The COVID-19 pathology is frequently associated with diabetes mellitus and metabolic syndrome. In the epidemic outbreak that exploded at the beginning of 2020 in the Lombardy Region, about two thirds of the patients who died from COVID-19 were affected by diabetes mellitus. COVID-19 occurs in 70% of cases with an inflammatory pathology of the airways that can be fed by a cytokine storm and result in severe respiratory failure (10% cases) and death (5%). The pathophysiological molecular mechanisms are currently not clearly defined. It is hypothesized that the transmembrane glycoprotein type II CD26, known for the enzyme activity Dipeptilpeptidase 4 of the extracellular domain, may play a main role in this condition. It is in fact considerably expressed at the level of parenchyma and pulmonary interstitium and carries out both systemic and paracrine enzymatic activity, modulating the function of various proinflammatory cytokines, growth factors and vasoactive peptides in the deep respiratory tract. Of particular interest is the fact that Dipeptilpeptidase 4 has been identified as a cellular receptor for S glycoprotein of MERS-COV. In the case of the SARS-COV 2 virus, the main receptor is the Angiotensin-Converting Enzyme 2 protein, but a possible interaction with Dipeptilpeptidase 4 also cannot be excluded. The selective blockade of Dipeptilpeptidase 4 could therefore favorably modulate the pulmonary inflammatory response in the subject affected by COVID-19. This protein is also known for the enzymatic degradation function of the native glucagon-like peptide 1, one of the main regulators of insulin secretion. This is why it is a molecular target in the treatment of diabetes (drugs that selectively inhibit Dipeptilpeptidase 4 are marketed with an indication for the treatment of type 2 diabetes). It is believed that the use of a Dipeptilpeptidase 4 inhibitor in people with diabetes and hospitalized for Covid-19 may be safe and of particular interest for an evaluation of the effects on laboratory and instrumental indicators of inflammatory lung disease. Among the drugs that selectively block Dipeptilpeptidase 4, the one with the greatest affinity is Sitagliptin.

NCT04365517
Conditions
  1. Covid19
  2. Diabetes Mellitus, Type 2
  3. CKD
Interventions
  1. Drug: Sitagliptin
MeSH:Diabetes Mellitus, Type 2
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Evaluation of the time between randomization and two-point improvement on a seven-category scale (1, not hospitalized, return to normal activities; 2, not hospitalized, but unable to return to normal activities; 3, hospitalized without the need for oxygen therapy; 4, hospitalized, need for oxygen therapy; 5, hospitalized, need for non-invasive ventilatory support; 6, hospitalized, need for invasive mechanical ventilation or Extra Corporeal Membrane Oxygenation; 7, death)

Measure: Time for clinical improvement

Time: 1 month

Description: Clinical evaluation of the physiological parameter "cough" associated with acute lung disease from the start of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "glycemia" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "need for ventilatory support" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameters "duration in days of ventilatory support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameters of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of the clinical parameter "PaO2/FiO2 ratio" of acute lung disease from the beginning of the study to the end of the study.

Measure: Clinical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Description: Variation of biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of study.

Measure: Biochemical parameter of acute lung disease

Time: 1 month

Secondary Outcomes

Description: The alteration of Dipeptilpeptidase 4 expression will be evaluated in the collected biological samples

Measure: Dipeptilpeptidase 4 expression in biological samples

Time: 6 months

Description: Evaluation of inflammatory cytokines IL-2 and IL-7 in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months

Description: Effect on glycemic variability by evaluating HbA1c levels.

Measure: Glycemic variability

Time: 1 month

Description: Effect on glycemic variability by evaluating the average daily blood glucose levels.

Measure: Glycemic variability

Time: 1 month

Description: Evaluation of the inflammatory cytokine granulocyte-colony stimulating factor in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months

Description: Evaluation of the inflammatory cytokine interferon-γ inducible protein 10 in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months

Description: Evaluation of the inflammatory cytokine monocyte chemoattractant protein 1 in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months

Description: Evaluation of the inflammatory cytokine macrophage inflammatory protein 1-α in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months

Description: Evaluation of the inflammatory cytokine tumour necrosis factor-α in biological samples of treated patients and control group patients during infection.

Measure: Cytokine-inflammatory profile

Time: 6 months
6 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. In
  15. Incretins
  16. Hormones
Interventions
  1. Drug: Linagliptin 5 MG
MeSH:Coronavir 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
7 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)
8 Virtually Delivered Lifestyle Program Integrating Wearable Technology and Exercise Prescriptions in Patients With Type 2 Diabetes (STAND-VAT): A Feasibility Study

The Primary Care Diabetes Support Program (PCDSP) offers a lifestyle medicine program, STAND, that patients can self-select themselves to participate. STAND offers biweekly, one-hour educational classes. With the onset of COVID-19, the clinic has moved virtually, but has yet to offer an individualized exercise program. Little evidence is available on utilizing telemedicine and wearable technologies combined in a clinical exercise setting. This is a 6-week single cohort prospective study assessing the feasibility of incorporating wearable activity trackers and individualized exercise prescriptions in the PCDSP's virtually delivered, STAND program in an adult population with type 2 diabetes mellitus. Roughly 15-20 participants will be recruited. Participants will attend the bi-weekly STAND classes and track their step counts daily using FitBits, trying to achieve individually prescribed step counts. Participants receive a brief follow up phone call every other week. The primary outcomes assessed will be recruitment and retention rates, as well as acceptability of, and adherence to, the virtual program. Acceptability will be assessed by an exit survey and mean number of reported technological issues. Adherence will be number of classes attended. Change in self-efficacy levels, diabetes emotional related distress, exercise volume, glucose control and fitness levels will secondarily be assessed.

NCT04498819
Conditions
  1. Type 2 Diabetes
  2. Comorbidities and Coexisting Conditions
Interventions
  1. Behavioral: Wearable Activity Trackers, Exercise Prescription and Virtual Care
MeSH:Diabetes Mellitus, Type 2
HPO:Type II diabetes mellitus

Primary Outcomes

Description: Recruitment levels will be defined as the number of people signed up over number of eligible people approached at intake and in class, presented as a percentage of sign up rates.

Measure: Feasibility: Recruitment

Time: from the date of of the first participant recruited the last participant recruited for the study (estimated last date for recruitment cut off is November 14th, 2020; allowing for study data collection completion by December 18, 2020).

Description: Retention will be calculated as number of participants completed post-intervention follow-up assessment divided by initial sample size.

Measure: Feasibility: Retention

Time: From time of consent and up to 9 weeks later (study completion)

Description: Acceptability will be assessed from participant feedback from the exit survey. Acceptability data gathered from the exit survey will be analyzed in a qualitative or descriptive fashion, using frequencies and means (i.e. "this many rated the lottery draw as a motivation to get them to attend class as "strongly agree": 93%"). Technical difficulties will be dealt with (by contact) and recorded by the Master's student in the STAND-VAT activity log. Number of reported technology issues will be reported as a total in addition to average mean # of technology issues per person. Counting will be used based on type of issue using categories like: a) lost/disrupted internet connection or unable to connect or hear or see during class; b) issues utilizing FitBit/FitBit app c) Issues with uploading FitBit data; d) other. Difficulty assessment will provide insight for improvements for larger future studies.

Measure: Feasibility: Acceptability

Time: Week 1 of intervention up to time of follow up (7 weeks later)

Description: Adherence will be assessed by the percent of biweekly classes attended and check-in phone calls answered, as well as number of data submissions (all out of three).

Measure: Feasibility: Adherence

Time: Week 1 of intervention to week 6

Secondary Outcomes

Description: The change in daily step counts will be measured using repeated, average daily step counts each week collected by the FitBit Inspire HR© during baseline, W1-W6. The mean number of change in daily step counts will be reported.

Measure: Participant Behaviour; Exercise Behaviours: Daily Step Count

Time: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)

Description: The hourly move goals are used to break and reduce sedentary behaviour. Change in sedentary time will be measured using repeated weekly average daily sedentary minutes collected by the FitBit Inspire HR©, during baseline, W1-W6.

Measure: Participant Behaviour; Exercise Behaviours: Daily Sedentary Time

Time: 1-week Baseline to end of week 6 of intervention (total 7 weeks assessed)

Description: Adherence to the exercise prescription will be measured by the total number of daily step goals achieved divided by number of days participated throughout the six weeks. The step goals completion numbers demonstrate intervention acceptability and will allow for further reflection on the achievability and appropriate progression rate of the exercise prescriptions. This will be presented as a percentage, calculated by number of days with step goals achieved over total number of days of the program.

Measure: Participant Behaviour; Exercise Behaviours: Exercise Prescription Adherence

Time: week 1 to week 6 of intervention

Description: Weekly average daily time in glycemic target will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.

Measure: Glycemic Control Measures: Time in Glycemic Target

Time: Weekly assessment from week 1 to week 6 of intervention

Description: At the clinic, A1c levels are routinely collected every three months. However, since this is a six-week study, A1c will be measured using the weekly average estimated A1c reading from Week 1 (when the first FreeStyle Libre is applied) and each week until week 6.

Measure: Glycemic Control Measures: Estimated A1c

Time: Weekly assessment from week 1 to week 6 of intervention

Description: Weekly average percent coefficient of variation will be repeatedly measured from the first week of the intervention week one (W1) (when the first FreeStyle Libre is applied) and each week until W6.

Measure: Glycemic Control Measures: Percent Coefficient of Variation

Time: Weekly assessment from week 1 to week 6 of intervention

Description: Functional fitness levels will be assessed using the two-minute step test. The two minute step test is a two minute, sub maximal test requiring participants to step on the spot, brining knees to mid-thigh level. Scoring is based on number of times the right knee rises within the two minutes.

Measure: Functional Fitness Levels

Time: At Baseline and at post-intervention follow-up (7 weeks later)

Description: Chronic disease self-efficacy will be measured using the Stanford Self-Efficacy Scale. The Stanford Self-Efficacy Scale is a reliable, validated six-item questionnaire that assesses the self-efficacy to manage a chronic disease, including exercise (Lorig et al., 2001; Ritter & Lorig, 2014). Scores range from 1 (not confident) to 10 (very confident). Higher scores mean higher self-efficacy.

Measure: Participant Attitudes: Chronic Disease Self-Efficacy

Time: At Baseline and at post-intervention follow-up (7 weeks later)

Description: Diabetes related emotional distress will be measured using the PAID-5. The five item Problem Areas in Diabetes Scale (PAID-5) is a valid and reliable short version of the PAID Scale, focusing on emotional distress scale (McGuire et al., 2010). Each question is ranked from zero (not a problem) to four (serious problem). A total score of eight or greater indicates possible emotional distress and may warrant further investigation.

Measure: Participant Attitudes: Diabetes Emotional Distress

Time: At Baseline and at post-intervention follow-up (7 weeks later)
9 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
10 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
11 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
12 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

HPO Nodes


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.

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691 reports on MeSH terms

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263 reports on HPO terms

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