Actively Recruiting
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Led by VA Office of Research and Development · Updated on 2025-11-14
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
U
University of Missouri-Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of empagliflozin, a medication that inhibits SGLT2, on arterial stiffness in Veterans with obesity. This randomized, double-blinded, placebo-controlled Phase 2 trial aims to understand how 12 weeks of empagliflozin treatment impacts arterial health compared to a placebo. The study will recruit 50 Veterans aged 30 to 60 years with a body mass index (BMI) between 30 and 45 kg/m2 who show evidence of arterial stiffening. Participants will be randomly assigned to receive either 10 mg of empagliflozin daily or a matching placebo for 12 weeks. The trial involves two groups: one receiving the active drug and the other receiving placebo tablets, both taken once daily. This treatment period will be closely monitored to assess the medication's impact on arterial stiffness. During the study, participants will undergo assessments of carotid-femoral pulse wave velocity (cfPWV) at baseline, week 4, week 8, and week 12 to measure changes in arterial stiffness. Researchers will monitor safety and adherence throughout the trial. The total participation lasts about 12 weeks, during which various health evaluations will be conducted to gauge the effects of the treatment on vascular health.
CONDITIONS
Brief Title
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 30 and 45 kg/m2
- Age between 30 and 60 years at randomization
- Evidence of arterial stiffening defined by carotid femoral pulse wave velocity greater than age-predicted values at screening
You will not qualify if you...
- Unable to provide consent
- Diagnosis of diabetes mellitus
- Uncontrolled hypertension with blood pressure over 180/90 mmHg or systolic pressure below 100 mmHg at screening
- Known history of cardiovascular disease including heart failure, ischemic heart disease, peripheral artery disease, or stroke
- Diagnosis of chronic kidney disease
- Active cancer except basal cell carcinoma or stage 1 squamous cell carcinoma of the skin
- Excessive alcohol consumption (more than 14 drinks/week for men, more than 7 drinks/week for women)
- Use of GLP-1 analogs or SGLT2 inhibitors
- Use of hormone replacement therapy
- Use of medications for weight loss
- Body weight changes over 10% within the past 6 months
- History of hypersensitivity to nitrates
- History of ketoacidosis
- History of recurrent urinary tract infections or mycotic genital infections
- Use of anticoagulants
- Change in anti-hypertensive medication in the last 90 days
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 12 weeks of daily treatment with either 10mg empagliflozin or matching placebo to assess effects on arterial stiffness.
4 visits at baseline, week 4, week 8, and week 12
Trial Site Locations
Total: 1 location
1
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States, 65201-5275
Actively Recruiting
Research Team
J
Jaume Padilla Parellada, PhD
K
Katherine M Burr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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