Clinical trial

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Name

52647

Description

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.

Trial arms

Trial start

2020-07-01

Estimated PCD

2023-12-31

Trial end

2023-12-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Ertugliflozin

Consenting participants in the Ertugliflozen group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.

Arms:

Ertugliflozin

Other names:

SGLT2 inhibitor

Glipizide

Consenting participants in the Glipizide group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.

Arms:

Glipizide

Size

Primary endpoint

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

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

Eligibility criteria

Inclusion Criteria: * patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery * history of Diabetes Mellitus Type 2 currently taking metformin or diet-controlled Exclusion Criteria: * allergy or intolerance to interventional medication * currently taking any anti-diabetic medication other than metformin

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'unblinded randomized trial', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-08-14

1 organization

2 products

4 indications

Organization

Stanford University

Product

Ertugliflozin

Indication

Cardiovascular Diseases

Indication

Indication

Indication

Product