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Clinical Trial Details

Trial ID: L6428
Source ID: NCT04167761
Associated Drug: Ertugliflozin
Title: Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Cardiovascular Diseases|Atherosclerosis|Type 2 Diabetes|Insulin Resistance
Interventions: DRUG: Ertugliflozin
Outcome Measures: Primary: Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples., Analysis will be performed using Lipolysis Colorimetric Assay and measured by glycerol content on standard curve. Indirect effects of SGLT2i in vivo in epicardial adipose tissue will be compared to Glipizide by measuring rate of lipolysis, or breakdown of adipose in to free fatty acids., Time to collect tissue collected during surgery (up to 15 minutes) | Secondary: Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples., Mature adipocytes will be isolated, cultured, and treated with 2-NBDG, a fluorescently-labeled deoxyglucose analog, as a probe for the detection of glucose uptake measured by excitation/emission of florescence in the mature cells., Time to collect tissue collected during surgery (up to 15 minutes)|Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples., Analysis will be performed using Luminex to measure levels of inflammatory cytokines on the human adipocyte panel., Time to collect tissue collected during surgery (up to 15 minutes)|Distribution of adipose cell size in epicardial tissue., After tissue collection and osmium fixation, adipose cell size will be determined by Beckman Coulter Multisizer III, and described via a mathematical model to estimate peak diameter, fat storage capacity, size variability, and % small cells., Time to collect tissue collected during surgery (up to 15 minutes)
Sponsor/Collaborators: Sponsor: Stanford University | Collaborators: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: EARLY_PHASE1
Enrollment: 61
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-07-01
Completion Date: 2023-12-31
Results First Posted:
Last Update Posted: 2024-12-20
Locations: Stanford University, Stanford, California, 94305, United States
URL: https://clinicaltrials.gov/show/NCT04167761