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Clinical Trials/NCT04167761
NCT04167761
Completed
Early Phase 1

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Stanford University1 site in 1 country61 target enrollmentJuly 1, 2020

Overview

Phase
Early Phase 1
Intervention
Ertugliflozin
Conditions
Cardiovascular Diseases
Sponsor
Stanford University
Enrollment
61
Locations
1
Primary Endpoint
Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tracey McLaughlin

Professor of Medicine

Stanford University

Eligibility Criteria

Inclusion Criteria

  • patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
  • history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors

Exclusion Criteria

  • allergy or intolerance to interventional medication
  • currently taking insulin, glp-1 inhibitors, or sulfonylureas

Arms & Interventions

Ertugliflozin (treated tissue)

Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues

Intervention: Ertugliflozin

Outcomes

Primary Outcomes

Rate of isoproterenol-stimulated lipolysis to measure metabolic flexibility in epicardial adipose tissue samples.

Time Frame: Time to collect tissue collected during surgery (up to 15 minutes)

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.

Secondary Outcomes

  • Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples.(Time to collect tissue collected during surgery (up to 15 minutes))
  • Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples.(Time to collect tissue collected during surgery (up to 15 minutes))
  • Distribution of adipose cell size in epicardial tissue.(Time to collect tissue collected during surgery (up to 15 minutes))

Study Sites (1)

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