Ertugliflozin: Cardioprotective Effects on Epicardial Fat

NCT04167761 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 52647
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Atherosclerosis; Type 2 Diabetes; Insulin Resistance

Keywords

Epicardial Adipose Tissue; SGLT2 Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Arms (1)

Ertugliflozin (treated tissue)

EXPERIMENTAL

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

Drug: Ertugliflozin

Interventions

Ertugliflozin DRUG

Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue

Also known as: SGLT2 inhibitor

Ertugliflozin (treated tissue)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Atherosclerosis; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

ertugliflozin; Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Tracey McLaughlin, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: in vitro experimental study with treated and control tissue samples

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)