Using empagliflozin to reduce arterial stiffness in older adults
SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging
This study is testing if a medication called empagliflozin can help older adults aged 60 to 80 reduce stiffness in their arteries over 12 weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06506422 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled study involving 80 participants aged 60 to 80 years. The study aims to investigate the effects of empagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, on arterial stiffness over a 12-week period. Participants will receive either empagliflozin or a matching placebo, with the hypothesis that empagliflozin will significantly reduce aging-related arterial stiffening compared to the placebo group. The trial will measure arterial stiffness using carotid-femoral pulse wave velocity (PWV) as a primary outcome.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy older adults aged 60 to 80 years who exhibit signs of arterial stiffness but do not have diabetes or significant cardiovascular disease.
Not a fit: Patients with diabetes, significant cardiovascular conditions, or those with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to mitigate arterial stiffness in older adults, potentially improving cardiovascular health.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can reduce cardiovascular events and arterial stiffness in various populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide consent * 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses) * Stable anti-hypertensive medication regimen (if in use) for at least 90 days * Evidence of arterial stiffening (defined as carotid-femoral PWV \>/= 8 m/s) at the time of screening visit. Exclusion Criteria: * Diabetes * BMI\>/= 45kg/m2 * Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke * Estimated glomerular filtration rate GFR \< 29 mL/min * 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 hormone replacement therapy * Body weight change ≥10% within the last 6 months * Uncontrolled hypertension during screening visit (\>180/110 mmHg) * Symptomatic hypotension and/or a SBP \<100 mmHg * History of ketoacidosis * High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements) * Anticipated need of prolonged fasting * History of recurrent UTIs or mycotic genital infections * Following a low-carbohydrate diet (\<20 grams/day) * Participation in regular exercise \> 3 days/week per week at a moderate or vigorous intensity * Known sensitivity to nitrate medications
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Camila Manrique, MD
- Email: manriquec@health.missouri.edu
- Phone: (573) 882-2554
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.