Obesity, Vascular Health
Conditions
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.
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
DRUGEmpagliflozin
12 week treatment with 10mg empagliflozin daily
DRUGPlacebo
12 week treatment with 10mg placebo daily
Sponsors
University of Missouri-Columbia
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blinded
Intervention model description
placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid-femoral Pulse Wave Velocity (cfPWV) | baseline (t0), week 4, week 8, week 12 | cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points. |
Countries
United States
Contacts
Primary ContactJaume Padilla Parellada, PhD
Backup ContactKatherine M Burr
Outcome results
None listed