Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
Recruiting · NCT06745063 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
EmpagliflozinPlacebo
What this trial is 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.
Who can take part
Age range
30 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Harry S. Truman Memorial, Columbia, MO - Columbia, Missouri, United States