The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

Conditions

• Metabolic Syndrome
• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin 25 MG — DRUG
  Empagliflozin is an FDA-approved SGLT2 inhibitor used for the treatment of type 2 diabetes, with off-label use for diabetic kidney disease and for heart failure with reduced ejection fraction even in those without diabetes.
• Placebo — DRUG
  Placebo consists of gelatin capsules.

Study Details

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 trial 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.

Key Dates

Start date

Sep 6, 2023

Status verified

Jun 2025

Primary completion

Sep 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

74 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Empagliflozin Arm
  Empagliflozin is an FDA-approved SGLT2 inhibitor used for the treatment of type 2 diabetes, with off-label use for diabetic kidney disease and for heart failure with reduced ejection fraction even in those without diabetes. To ensure blinding, empagliflozin will be over-encapsulated in identical gelatin capsules as placebo.
• Placebo Comparator: Placebo Arm
  Placebo consists of gelatin capsules.

Primary Outcome Measure

Adipose tissue macrophages [ Time Frame: 12 weeks ]

Central Contacts

• Mona Mashayekhi, MD, PhD
  615-208-5037
  [email protected]

Locations (1)

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