NCT06745063 Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
| NCT ID | NCT06745063 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-05-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Jaume Padilla Parellada, PhD
PRINCIPAL INVESTIGATOR
Harry S. Truman Memorial, Columbia, MO
Frequently Asked Questions
Who can join the NCT06745063 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06745063 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06745063 currently recruiting?
Yes, NCT06745063 is actively recruiting participants. Contact the research team at jaume.padillaparellada@va.gov for enrollment information.
Where is the NCT06745063 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT06745063 clinical trial?
NCT06745063 is sponsored by VA Office of Research and Development. The principal investigator is Jaume Padilla Parellada, PhD at Harry S. Truman Memorial, Columbia, MO. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.