Clinical trial

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06745063

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Vascular Health

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

Treatments and study arms

Empagliflozin

Drug

12 week treatment with 10mg empagliflozin daily

Placebo

Drug

12 week treatment with 10mg placebo daily

Primary outcomes

Carotid-femoral Pulse Wave Velocity (cfPWV)baseline (t0), week 4, week 8, week 12

cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Harry S. Truman Memorial, Columbia, MO🇺🇸 Columbia, Missouri, United States

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Jaume Padilla Parellada, PhDContact

Email · Call 573-814-6552

Jaume Padilla Parellada, PhDPrincipal Investigator