Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Mayo Clinic
- Study ID
- NCT07057310
- Phase
- PHASE4
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 46 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- semaglutide or tirzepatide — DRUGSemaglutide and tirzepatide will be dosed as per prescription labels
- Lifestyle modification intervention — BEHAVIORALAll participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).
Study Details
In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. The goal is to determine the effect of weight loss induced by the new generation of GLP-1 receptor agonists on physical function, aging biomarkers, and vascular function in postmenopausal women with obesity.
Key Dates
- Start date
- May 1, 2025
- Status verified
- Jun 2025
- Primary completion
- Dec 31, 2026
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Weight loss medication and standard lifestyle interventionSubjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention.
- Active Comparator: Standard lifestyle intervention onlySubjects will receive standard of care lifestyle intervention only.
Primary Outcome Measure
Physical Function Measure: Short Physical Performance Battery (SPPB) score. [ Time Frame: 24 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | - |
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