NCT05885074

Mechanistic Insights to Weight Loss Maintenance Through SGLT2 Inhibitors

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Obesity increases the risk of cardiometabolic diseases such as hypertension and diabetes. Weight loss interventions such as low-calorie diet and physical activity are effective for weight loss in the short term, but weight loss maintenance (WLM) with low-calorie diet and physical activity is challenging. Weight loss is associated with a reduction in the amount of calories needed to maintain the body at rest, called the resting energy expenditure (REE), which may be a probable mechanism for this lack of WLM. Most individuals are unable to adequately change their diet and increase their physical activity levels to overcome this decrease in REE which prevents WLM. Therefore, techniques that increase REE may promote WLM in these individuals. Pre-clinical studies for Empagliflozin - Sodium-glucose Cotransporter-2 (SGLT2) inhibitor have shown an increase in REE. Thus, in addition to reducing the cardiovascular risk, SGLT2 inhibitor may promote WLM by increasing REE. This study aims to promote WLM in obese individuals by increasing the REE using SGLT2 inhibitor therapy.

Conditions

• Obesity
• Weight Loss

Interventions

Type	Name	Description
DRUG	Empagliflozin Arm	The subject will be randomized, in a double-blind manner to Empagliflozin 25mg once daily for a period of 12 months
OTHER	Control Arm	The subject will be randomized, in a double-blind manner to receive placebo once daily for a period of 12 months
OTHER	Exercise capacity VO2 maximum determination	Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol and will also undergo a DEXA scan to determine the body mass.
OTHER	Exercise Challenge	Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill and will also undergo a resting energy expenditure test.

Timeline

• Start date: 2025-01-30
• Primary completion: 2026-01-30
• Completion: 2027-06-30
• First posted: 2023-06-01
• Last updated: 2024-08-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study