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NCT06745063PHASE2RecruitingAccepts Healthy Volunteers

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

VA Office of Research and Development

Start Date

5/30/2025

Completion Date

12/31/2029

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.

Detailed Description

The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10mg daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45kg/m2), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.

Eligibility Criteria

Age Range: 30 years to 60 years

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 infections * Use of anticoagulants * Change in anti-hypertensive medication regimen (if in use) during the last 90 days * Pregnancy

Interventions

DRUG

Empagliflozin

DRUG

Placebo

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Conditions

ObesityVascular Health

Locations

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri 65201-5275

United States