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Recruiting Phase 2 NCT06745063

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Trial Parameters

Condition Obesity
Sponsor VA Office of Research and Development
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 50
Sex ALL
Min Age 30 Years
Max Age 60 Years
Start Date 2025-05-30
Completion 2028-12-31
Interventions
EmpagliflozinPlacebo

Brief 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 Criteria

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

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