Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Cardiovascular Diseases Clinical Trial

Official title:

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04167761
• Other study ID #: 52647
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Insulin Resistance
• Type 2 Diabetes

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average insulin mediated glucose uptake (IMGU) to measure insulin sensitivity in epicardial adipose tissue samples.	Mature adipocytes will be isolated, cultured, and treated with 2-NBDG, a fluorescently-labeled deoxyglucose analog, as a probe for the detection of glucose uptake measured by excitation/emission of florescence in the mature cells.	Time to collect tissue collected during surgery (up to 15 minutes)
Secondary	Characterization of the inflammatory cytokine expression profile in epicardial adipose tissue samples.	Analysis will be performed using Luminex to measure levels of inflammatory cytokines on the human adipocyte panel.	Time to collect tissue collected during surgery (up to 15 minutes)
Secondary	Distribution of adipose cell size in epicardial tissue.	After tissue collection and osmium fixation, adipose cell size will be determined by Beckman Coulter Multisizer III, and described via a mathematical model to estimate peak diameter, fat storage capacity, size variability, and % small cells.	Time to collect tissue collected during surgery (up to 15 minutes)