Empagliflozin to reduce arterial stiffness in veterans with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body mass index (BMI) 30-45 kilograms per square meter (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), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents

Exclusion Criteria:

* Unable to provide consent
* Diabetes mellitus
* Uncontrolled hypertension (\>180/90 millimeters of mercury) or systolic \<100 millimeters of mercury 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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.