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Ertugliflozin: Cardioprotective Effects on Epicardial Fat

NCT ID: NCT04167761

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Diseases Atherosclerosis Type 2 Diabetes Insulin Resistance

Keywords

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Epicardial Adipose Tissue SGLT2 Inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

in vitro experimental study with treated and control tissue samples
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ertugliflozin

Intervention Type 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

Interventions

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Ertugliflozin

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

Intervention Type DRUG

Other Intervention Names

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SGLT2 inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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52647

Identifier Type: -

Identifier Source: org_study_id