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NCT06745063 | NOT YET RECRUITING | Obesity

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
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.

Condition or disease

Obesity

Vascular Health

Intervention/treatment

Empagliflozin

Placebo

Phase

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : TRIPLE
Masking Description : double-blinded
Primary Purpose : TREATMENT
Official Title : Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Actual Study Start Date : 2025-05-30
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Location Details

NCT06745063

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How to Participate

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Locations

Not yet recruiting

United States, Missouri

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, United States, 65201-5275