Empagliflozin to reduce arterial stiffness in veterans with obesity
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
This 12-week trial will test whether taking empagliflozin can reduce arterial stiffness in veterans with obesity compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06745063 on ClinicalTrials.gov |
What this trial studies
This double-blind, randomized, placebo-controlled Phase 2 trial will compare empagliflozin 10 mg daily to matching placebo for 12 weeks in 50 veterans with obesity (BMI 30–45 kg/m2) aged 30–60 recruited at the Harry S. Truman Memorial VA Hospital in Columbia, Missouri. Eligible participants must demonstrate arterial stiffening at screening as defined by carotid–femoral pulse wave velocity above age-predicted values. The primary outcome is change in arterial stiffness measured by carotid–femoral pulse wave velocity after 12 weeks, with safety and tolerability monitored throughout. Randomization and blinding are used to minimize bias in estimating the drug’s effect.
Who should consider this trial
Good fit: Ideal candidates are veterans aged 30–60 with BMI 30–45 kg/m2 who have evidence of arterial stiffening and do not have diabetes, significant cardiovascular disease, or chronic kidney disease.
Not a fit: Patients with diabetes, established cardiovascular disease, chronic kidney disease, current use of SGLT2 inhibitors or GLP-1 agents, or those outside the specified BMI and age ranges are unlikely to be eligible or to benefit from this trial.
Why it matters
Potential benefit: If successful, empagliflozin could lower arterial stiffness and improve vascular health, potentially reducing long-term cardiovascular risk in veterans with obesity.
How similar studies have performed: SGLT2 inhibitors have shown cardiovascular and renal benefits in people with diabetes and small studies suggest possible improvements in vascular stiffness, but arterial destiffening in non-diabetic obesity is still relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbia, Missouri
- Harry S. Truman Memorial, Columbia, MO — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jaume Padilla Parellada, PhD — Harry S. Truman Memorial, Columbia, MO
- Study coordinator: Jaume Padilla Parellada, PhD
- Email: jaume.padillaparellada@va.gov
- Phone: (573) 814-6552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.