SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot

Phase 1

Completed

• Conditions: Obesity; Pre-diabetes
• Interventions: Drug: Empagliflozin 25 MG

• Registration Number: NCT04907214
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.

Detailed Description

This study will be expanded to include another 10 participants. Enrollment will begin July 1, 2023.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-28
• Study Start: 2021-07-29
• Results First Submitted: 2022-11-27
• Results First Submitted QC: 2023-01-11
• Results First Posted: 2023-02-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-08
• Study Completion: 2023-12-08
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 25 MG	Individuals receive empagliflozin 25mg/day orally for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 3 Months	Baseline to 12 weeks	Pro-inflammatory T helper type 1 cells are quantified using flow cytometry
Change in Flow-mediated Dilation After 3 Months	Baseline to 12 weeks	Endothelial function quantified using flow-mediated dilation by ultrasound, measuring percentage increase in artery diameter during hyperemia.
Change in Liver Steatosis at 3 Months	Baseline to 12 weeks	Liver steatosis assessment by transient elastography-controlled attenuation parameter imaging, reported as Controlled Attenuation Parameter (CAP)

Secondary Outcome Measures

Name	Time	Method
Change in Adipose Pro-inflammatory T Helper Type 1 Cell Percentages After 2 Weeks	Baseline to 2 weeks	Pro-inflammatory T cells are quantified using flow cytometry
Change in the Plasma Inflammatory Cytokine IL-6 After 3 Months	Baseline to 12 weeks	IL-6 is quantified in plasma samples.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States