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Recruiting NCT06745063

Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Phase II Interventional Obesity Vascular Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin, Placebo.
Who it may be relevant to
Registry conditions: Obesity, Vascular Health. Basic parameters: 30 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Empagliflozin
    12 week treatment with 10mg empagliflozin daily
  • Drug Placebo
    12 week treatment with 10mg placebo daily

Primary outcome measures

  • Carotid-femoral Pulse Wave Velocity (cfPWV) [Time frame: baseline (t0), week 4, week 8, week 12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Harry S. Truman Memorial, Columbia, MO — Columbia

Identifiers

NCT: NCT06745063 · CARB-015-24S · 2107866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗