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Clinical Trial Details

Trial ID: L5728
Source ID: NCT03313752
Associated Drug: Dapagliflozin 10mg Tab
Title: Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity
Acronym: DapaHeart
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus|Stable Coronary Artery Disease
Interventions: DRUG: Dapagliflozin 10Mg Tab|OTHER: Placebo
Outcome Measures: Primary: Effect of dapagliflozin on myocardial insulin sensitivity, Myocardial Glucose Uptake (MGU) umol/min/gr during euglycemic hyperinsulinemic clamp: change from baseline, 4 weeks | Secondary: Effect on Coronary flow reserve [Main Secondary Outcome], Coronary flow reserve (CFR) obtained as ratio of myocardial blood flow (ml/min/g) (MBF) during pharmacological stress and MBF at rest: change from baseline, 4 weeks|3. Browning of white adipose tissue: change from baseline, Quantitative measurement of FDG uptake in pericardial, perirenal, interscapular fat by total body FDG PET-CT study, expressed as maximum Standard Uptake Volume (SUVmax) (change from baseline), 4 weeks|Metabolic systemic effects of dapagliflozin, Whole body glucose uptake calculated as mg/kg/min during the euglycemic hyperinsulinemic clamp: change from baseline, 4 weeks|Effect on Left Ventricular Ejection Fraction at rest, Whole body glucose uptake calculated as mg/kg/min during the euglycemic hyperinsulinemic clamp: change from baseline, 4 weeks|Effect on Left Ventricular Ejection Fraction during pharmacological stress, Left Ventricular Ejection Fraction (percent %) measured by Gated-PET with 13N-ammonia during pharmacological stress: change from baseline, 4 weeks|Fasting glucose concentration change from baseline, Measured as fasting glucose concentration (mg/dl): change from baseline, 4 weeks|Glycemic control change from baseline, Measured as Glycated hemoglobin (HbA1c) (percent %): change from baseline, 4 weeks|Gut microbiota composition change from baseline, Analysis of gut microbiota composition at class, genus, and species levels: change from baseline, 4 weeks
Sponsor/Collaborators: Sponsor: Andrea Giaccari
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 52
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2017-12-01
Completion Date: 2022-12-01
Results First Posted:
Last Update Posted: 2021-03-03
Locations: Center For Endocrine and Metabolic Diseases - Catholic University, Rome, RM, 00168, Italy
URL: https://clinicaltrials.gov/show/NCT03313752