The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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 criteria
Qualifiers
Age 18+ years old
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
Disqualifiers
Type 1 diabetes.
Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%.
Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.
Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.
Trial design
Treatments tested in this trial
- Empagliflozin 25 MG
- Placebo
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov