Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Phase 2

Not yet recruiting

• Conditions: Obesity; Vascular Health
• Interventions: Drug: Empagliflozin; Drug: Placebo

• Registration Number: NCT06745063
• Lead Sponsor: VA Office of Research and Development

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.

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.

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Study Start: 2025-05-30
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin	12 week treatment with 10mg empagliflozin daily
Placebo	Placebo	12 week treatment with 10mg placebo daily

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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