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D008659: Metabolic Diseases

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 (10)


Name (Synonyms) Correlation
drug4516 Two COVID-19 vaccine candidate (TMV-083) administrations - Low dose Wiki 0.45
drug2348 Linagliptin 5 MG Wiki 0.45
drug3649 Remote consultation Wiki 0.45
Name (Synonyms) Correlation
drug2950 One COVID-19 vaccine candidate (TMV-083) administration - High dose Wiki 0.45
drug2418 Low-Carbohydrate Diet Wiki 0.45
drug5256 teleconsultation Wiki 0.45
drug4515 Two COVID-19 vaccine candidate (TMV-083) administrations - High dose Wiki 0.45
drug175 AZD2693 Wiki 0.32
drug5083 no intervention Wiki 0.14
drug3195 Placebo Wiki 0.04

Correlated MeSH Terms (14)


Name (Synonyms) Correlation
D044882 Glucose Metabolism Disorders NIH 0.77
D004700 Endocrine System Diseases NIH 0.52
D008661 Metabolism, Inborn Errors NIH 0.45
Name (Synonyms) Correlation
D006943 Hyperglycemia NIH 0.26
D065626 Non-alcoholic Fatty Liver Disease NIH 0.26
D018149 Glucose Intolerance NIH 0.26
D005234 Fatty Liver NIH 0.26
D011236 Prediabetic State NIH 0.22
D003920 Diabetes Mellitus, NIH 0.21
D050177 Overweight NIH 0.13
D003924 Diabetes Mellitus, Type 2 NIH 0.10
D012140 Respiratory Tract Diseases NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0000818 Abnormality of the endocrine system HPO 0.52
HP:0011998 Postprandial hyperglycemia HPO 0.26
HP:0001397 Hepatic steatosis HPO 0.26
Name (Synonyms) Correlation
HP:0000819 Diabetes mellitus HPO 0.21
HP:0005978 Type II diabetes mellitus HPO 0.10

Clinical Trials

Navigate: Correlations   HPO

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

Primary Outcomes

Measure: Change in Hemoglobin A1c

Time: Baseline and six months

Secondary Outcomes

Measure: Change in fasting plasma glucose

Time: Baseline and six months

Measure: Change in systolic blood pressure

Time: Baseline and six months

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

Time: Baseline and six months

Measure: Change in body weight

Time: Baseline and six months

Other Outcomes

Measure: Change in insulin

Time: Baseline and six months

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

Time: Baseline and six months

Measure: Change in diastolic blood pressure

Time: Baseline and six months

Measure: Change in waist circumference

Time: Baseline and six months

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

Measure: Change in estimated cardiovascular disease risk

Time: Baseline and six months
2 A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2693 Following Single Ascending Dose Administration in Male and Female Subjects of Non-childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects

This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.

NCT04142424
Conditions
  1. Metabolic Disorders
  2. Non-alcoholic Steatohepatitis
Interventions
  1. Drug: AZD2693
  2. Drug: Placebo
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease Metabolic Diseases Overweight
HPO:Hepatic steatosis

Primary Outcomes

Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693

Measure: Number of subjects experiencing adverse events and serious adverse events

Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)

Secondary Outcomes

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)

Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)]

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

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

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

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

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.

Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Mean residence time (MRT)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Time delay between drug administration and the first observed concentration in plasma (tlag)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Time of the last quantifiable concentration (tlast)

Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose

Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693

Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]

Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-dose
3 Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19

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

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

Primary Outcomes

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

Measure: Time to clinical change

Time: 28 days

Secondary Outcomes

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

Time: 28 days

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

Measure: Percent of patients with clinical improvement.

Time: 28 days

Measure: Length of hospitalization.

Time: 28 days

Measure: All-cause mortality.

Time: 28 days

Measure: Percent of supplemental oxygen use.

Time: 28 days

Measure: Supplemental oxygen-free days.

Time: 28 days

Measure: Percent of mechanical ventilation use.

Time: 28 days

Measure: Ventilator-free days.

Time: 28 days

Measure: Percent of ICU admissions.

Time: 28 days

Measure: ICU-free days.

Time: 28 days

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

Time: Up to 28 days

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

Time: 28 days
4 Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

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

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

Primary Outcomes

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

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

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

Secondary Outcomes

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

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

Time: 6 weeks period following the end of the lockdown

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

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

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

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

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

Time: 6 weeks period following the end of the lockdown

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

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

Time: 6 weeks period following the end of the lockdown

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

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

Time: 6 weeks period following the end of the lockdown

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

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

Time: 6 weeks period following the end of the lockdown

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

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

Time: 6 weeks period following the end of the lockdown
5 Prospective Study on the Impact of COVID-19 on the Equilibrium of Hereditary Metabolic Disease (MHM) in Patients With or Who Have Contracted COVID-19

No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19. This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation. The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection

NCT04645498
Conditions
  1. Covid19
  2. Metabolism, Inborn Errors
MeSH:Metabolism, Inborn Errors Metabolic Diseases

Primary Outcomes

Description: disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.

Measure: Frequency of MHM imbalance triggered by COVID-19

Time: at 8 weeks

Secondary Outcomes

Measure: Number of COVID-19 patients in Gaucher's disease

Time: at 24 months

Measure: Number of COVID-19 patients in Urea Cycle Disorder

Time: at 24 months

Description: severity of COVID-19 infection as assessed by hospitalization; Intensive Care Unit, death

Measure: Severity of COVID-19 infection

Time: at 24 months

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on December 13, 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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Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

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Alphabetical index of all Terms

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