RecruitingPhase 2NCT06745063

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Sponsor

VA Office of Research and Development

Enrollment

50 participants

Start Date

May 30, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity Vascular Health

Summary

The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.

Eligibility

Min Age: 30 YearsMax Age: 60 Years

Inclusion Criteria3

Body mass index (BMI) 30-45 kg/m2
-60 years of age at randomization
Evidence of arterial stiffening (defined as Carotid femoral PWV>age-predicted) at screening visit (PMID: 20530030)

Exclusion Criteria17

Unable to provide consent
Diabetes mellitus
Uncontrolled hypertension (>180/90mmHg) or systolic <100mmHg at screening visit
Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
Diagnosis of chronic kidney disease
Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
Use of GLP-1 analogs or SGLT2 inhibitors
Use of hormone replacement therapy
Use of pharmacological therapy for weight loss
Body weight changes >10% within the past 6 months
History of hypersensitivity to nitrates
History of ketoacidosis
History of recurrent UTIs or mycotic genital infections
Use of anticoagulants
Change in anti-hypertensive medication regimen (if in use) during the last 90 days
Pregnancy