The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 18 to 70 years old

• Metabolic syndrome as defined by 3 or more of 5 criteria:

‣ Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month

⁃ Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)

⁃ High-density lipoprotein (HDL) \< 40 mg/dL in males or \< 50 mg/dL in females

⁃ Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications

⁃ Waist circumference ≥ 102 cm in males or ≥ 88cm in females

• BMI ≥ 35 kg/M2

• Scheduled gastric bypass or gastric sleeve in approximately 90 days (range 90-270 days)

• The ability to provide informed consent

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Mona Mashayekhi, MD, PhD
mona.mashayekhi@vumc.org
615-208-5037
Time Frame
Start Date: 2023-09-06
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 74
Treatments
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.
Sponsors
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov