Covid 19 Research using Clinical Trials (Home Page)
Report for D008659: Metabolic Diseases NIH
(Synonyms: Met, Metabo, Metabolic Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1626 | Low-Carbohydrate Diet Wiki | 0.58 |
| drug1576 | Linagliptin 5 MG Wiki | 0.58 |
| drug2250 | Prone position ventilation Wiki | 0.58 |
| drug3294 | hyperimmune plasma Wiki | 0.58 |
| drug3367 | no intervention Wiki | 0.22 |
Correlated MeSH Terms (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D044882 | Glucose Metabolism Disorders NIH | 1.00 |
| D004700 | Endocrine System Diseases NIH | 0.82 |
| D006943 | Hyperglycemia NIH | 0.58 |
| D018149 | Glucose Intolerance NIH | 0.58 |
| D003920 | Diabetes Mellitus, NIH | 0.41 |
| D011236 | Prediabetic State NIH | 0.41 |
| D003924 | Diabetes Mellitus, Type 2 NIH | 0.18 |
| D012140 | Respiratory Tract Diseases NIH | 0.12 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.05 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000818 | Abnormality of the endocrine system HPO | 0.82 |
| HP:0011998 | Postprandial hyperglycemia HPO | 0.58 |
| HP:0000819 | Diabetes mellitus HPO | 0.41 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.18 |
There are 3 clinical trials
Clinical Trials
1 Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial
The proposed randomized controlled trial will test the effect of a low-carbohydrate diet on hemoglobin A1c among individuals with elevated hemoglobin A1c that are within the range of prediabetes or diabetes. Results may provide evidence about the role of carbohydrate restriction in individuals with or at high risk of type 2 diabetes.
NCT03675360 Diabetes PreDiabetes Metabolic Disease Hyperglycemia Diet Modification Glucose Intolerance Glucose Metabolism Disorders (Including Diabetes Mellitus) Endocrine System Diseases Behavioral: Low-Carbohydrate Diet MeSH:Diabetes Mellitus Hyperglycemia Prediabetic State Glucose Intolerance Metabolic Diseases Glucose Metabolism Disorders Endocrine System Diseases
HPO:Abnormality of the endocrine system Diabetes mellitus Hyperglycemia Postprandial hyperglycemia
Primary Outcomes
Measure: Change in Hemoglobin A1c Time: Baseline and six months
Secondary Outcomes
Measure: Change in fasting plasma glucose Time: Baseline and six months
Measure: Change in systolic blood pressure Time: Baseline and six months
Measure: Change in total-to-HDL-cholesterol ratio Time: Baseline and six months
Measure: Change in body weight Time: Baseline and six months
Other Outcomes
Measure: Change in insulin Time: Baseline and six months
Measure: Change in homeostasis model assessment of insulin resistance (HOMA-IR) Time: Baseline and six months
Measure: Change in diastolic blood pressure Time: Baseline and six months
Measure: Change in waist circumference Time: Baseline and six months
Description: Based on 10-year cardiovascular disease risk assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score
Measure: Change in estimated cardiovascular disease risk Time: Baseline and six months
2 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
Primary Outcomes
Measure: Change in Hemoglobin A1c Time: Baseline and six monthsSecondary Outcomes
Measure: Change in fasting plasma glucose Time: Baseline and six monthsMeasure: Change in systolic blood pressure Time: Baseline and six months
Measure: Change in total-to-HDL-cholesterol ratio Time: Baseline and six months
Measure: Change in body weight Time: Baseline and six months
Other Outcomes
Measure: Change in insulin Time: Baseline and six monthsMeasure: Change in homeostasis model assessment of insulin resistance (HOMA-IR) Time: Baseline and six months
Measure: Change in diastolic blood pressure Time: Baseline and six months
Measure: Change in waist circumference Time: Baseline and six months
Description: Based on 10-year cardiovascular disease risk assessed by 2013 American College of Cardiology/American Heart Association Atherosclerotic Cardiovascular Disease Risk Score
Measure: Change in estimated cardiovascular disease risk Time: Baseline and six monthsThe 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 COVID 19 Coronavirus Diabetes Mellitus, Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases Dipeptidyl-Peptidase IV Inhibitors Linagliptin Severe Acute Respiratory Syndrome Coronavirus 2 Sars-CoV2 Hypoglycemic Agents Respiratory Tract Diseases Inc Incretins Hormones Drug: Linagliptin 5 MG MeSH:Coronaviru Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Diabetes Mellitus, Type 2 Metabolic Diseases Glucose Metabolism Disorders Respiratory Tract Diseases 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
3 Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study
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 daysSecondary Outcomes
Measure: Percent of serious adverse events and premature discontinuation of treatment. 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 daysMeasure: 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
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes. The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care. This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.
NCT04485351 Diabetes Mellitus Coronavirus Infection Metabolic Disease Glucose Metabolism Disorders Other: no intervention MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders
HPO:Diabetes mellitus
Primary Outcomes
Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Secondary Outcomes
Description: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy Time: 6 weeks period following the end of the lockdown
Description: Use BMI, lipid profile, renal and hepatic function from medical records
Measure: Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Description: Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
Measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown. Time: 6 weeks period following the end of the lockdown
Description: Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
Measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown. Time: 6 weeks period following the end of the lockdown
Description: Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco
Measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown. Time: 6 weeks period following the end of the lockdown
Description: Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)
Measure: Describe healthcare consumption of patients with diabetes during the lockdown. Time: 6 weeks period following the end of the lockdown
Description: Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.
Measure: Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19. Time: 6 weeks period following the end of the lockdown
HPO Nodes
Primary Outcomes
Description: HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.
Measure: Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic. Time: 6 months period prior to lockdown - 6 weeks period following the end of the lockdownSecondary Outcomes
Description: Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
Measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy Time: 6 weeks period following the end of the 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 lockdown