Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity (EMPA)

VA Office of Research and Development

Status and phase: Enrolling; Phase 2

Conditions: Obesity; Vascular Health

Treatments: Drug: Empagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06745063

CARB-015-24S

2107866 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Empagliflozin

Experimental group

Description:

12 week treatment with 10mg empagliflozin daily

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

Description:

12 week treatment with 10mg placebo daily

Treatment:

Drug: Placebo