Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called empagliflozin can improve arterial health in veterans who are dealing with obesity. Over 12 weeks, participants will either take empagliflozin or a placebo (a harmless pill with no active medication) to see if it helps reduce stiffness in their arteries. This stiffness can affect heart health, so the researchers are interested in understanding how the medication might help.

To join the study, participants need to be between 30 and 60 years old and have a body mass index (BMI) between 30 and 45, which indicates obesity. They also need to show signs of stiff arteries, which will be checked during a screening visit. However, certain individuals, like those with diabetes, high blood pressure that isn't controlled, or a history of heart problems, won't be able to participate. If eligible, participants can expect regular check-ins and assessments throughout the trial to monitor their health and the effects of the medication. This study is a great opportunity for eligible veterans to contribute to important research on improving vascular health.

Gender

ALL

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