NCT04907214

SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot

The Effect of SGLT2 Inhibition on Adipose Tissue Inflammation and Endothelial Function Pilot

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Pre-diabetes

Interventions

Type	Name	Description
DRUG	Empagliflozin 25 MG	Oral empagliflozin daily

Timeline

• Start date: 2021-07-29
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2021-05-28
• Last updated: 2023-12-29
• Results posted: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study