The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Vanderbilt University Medical Center
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 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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18 to 70 years old 2. Metabolic syndrome as defined by 3 or more of 5 criteria: 1. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month 2. Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids) 3. High-density lipoprotein (HDL) \< 40 mg/dL in males or \< 50 mg/dL in females 4. Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications 5. Waist circum…
Interventions
- DrugEmpagliflozin 25 MG
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.
- DrugPlacebo
Placebo consists of gelatin capsules.
Location
- Vanderbilt University Medical CenterNashville, Tennessee