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Completed

NCT Number: NCT04167761

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: SGLT2 inhibitor

Primary outcomes

  1. Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility

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

    The rate of lipolysis was measured under basal, isoproterenol-stimulated, and insulin-suppressed conditions in adipose tissue depots (epicardial, pericardial, and subcutaneous) treated with and without Ertugliflozin. Lipolysis was quantified using a colorimetric assay to determine metabolic flexibility. Cardiac adipose tissue explants cultured with ertugliflozin compared to mock condition.

Secondary outcomes

  1. Cytokine Secretion Profiles in Adipose Tissue Depots

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

    Levels of cytokines, including MCP1, TNF-β, IL-6, IFN-γ, and IL1-β, were measured in the culture medium of treated and untreated adipose tissue depots (epicardial, pericardial, and subcutaneous) using Luminex assays. Cytokine levels were used to characterize inflammation and response to Ertugliflozin treatment in cardiac adipose tissue explants) and isolated adipocytes after culture with Ertugliflozin vs mock condition.

  2. Adipose Cell Size Distribution in Pericardial and Subcutaneous Tissue

    Time frame: Time to process tissue samples collected during surgery (up to 15 minutes).

    Adipose cell size distribution was assessed in subcutaneous and pericardial adipose tissue samples using osmium fixation and cell diameter measurements. The relationship between cell size and Ertugliflozin treatment was analyzed.

Other outcomes

  1. Gene Expression Profiles in Adipose Tissue Depots

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

    Expression of genes related to inflammation and lipid metabolism (e.g., MCP1, TNF-β, IL-6) was measured in adipose tissue samples using mRNA extraction and RT-PCR after Ertugliflozin treatment. Analysis was performed to evaluate molecular changes in adipose depots (epicardial, pericardial, and subcutaneous).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2019
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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