Actively Recruiting
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Led by Vanderbilt University Medical Center · Updated on 2026-05-11
74
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of metabolic syndrome with at least three of the following: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg or treated with anti-hypertensive medication for at least 1 month
- Triglycerides ≥150 mg/dL or treated with triglyceride-lowering medication
- HDL cholesterol <40 mg/dL in males or <50 mg/dL in females
- Fasting blood glucose ≥100 mg/dL or treated with glucose-lowering medication
- Waist circumference ≥102 cm in males or ≥88 cm in females
- Body mass index (BMI) ≥35 kg/m2
- Scheduled for gastric bypass or gastric sleeve surgery within approximately 90 days (range 90-270 days)
- Ability to provide informed consent
You will not qualify if you...
- Diagnosis of type 1 diabetes
- Poorly controlled type 2 diabetes (HbA1c ≥9%)
- Use of anti-diabetic medications other than stable dose metformin or sulfonylurea in the last month
- Treatment with glucagon-like peptide-1 receptor agonist or co-agonist within the last 3 months
- Treatment with an SGLT2 inhibitor within the last 3 months
- Pregnancy or breastfeeding; women of childbearing potential must use effective contraception or have undergone sterilization
- Cardiovascular diseases including recent heart attack, angina, serious arrhythmias, heart failure (except left ventricular hypertrophy), deep vein thrombosis, pulmonary embolism, certain heart valve diseases, or hypertrophic cardiomyopathy
- Presence of implanted cardiac defibrillator or pacemaker
- History of serious neurological diseases such as stroke or transient ischemic attack
- History of pancreatitis or pancreatic surgery
- Immunological or hematological disorders
- Significant gastrointestinal issues affecting drug absorption
- Advanced liver disease with cirrhosis
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
- Use of chronic systemic glucocorticoids (more than 7 consecutive days in 1 month)
- Use of anticoagulants
- Any underlying or acute disease requiring regular medication that may affect safety or study interpretation
- History of alcohol abuse or illicit drug use
- Use of investigational drugs within one month before study
- Previous participation in this trial
- Mental conditions impairing understanding or compliance
- Inability to follow the study protocol or attend follow-ups
- History of balanitis in uncircumcised men
- History of urinary incontinence
- Frequent or severe vulvovaginitis
- History of Fournier's gangrene
- Recurrent urinary tract infections or pyelonephritis
- History of symptomatic low blood pressure or risk of dehydration
- Peripheral vascular disease, neuropathy, foot ulcers, or limb amputations
- Use of loop diuretics such as furosemide, torsemide, bumetanide, or ethacrynic acid
- Known or suspected allergy to study medications or related products
- Contraindications as listed in the medication prescribing information
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Mona Mashayekhi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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