Clinical trial
Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
Invitation only · Phase 4 · 1 countries · Registry ID NCT07057310
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
semaglutide or tirzepatide
Semaglutide and tirzepatide will be dosed as per prescription labels
Lifestyle modification intervention
All 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.).
Primary outcomes
The SPPB is a standardized test that evaluates lower extremity function using three components: balance tests (standing in various positions), gait speed (walking a short distance), and chair stand (repeated standing from a seated position). Each component is scored from 0 to 4; the total score ranges from 0 to 12. Higher scores represent better physical function.
The mCTSIB assesses balance under four sensory conditions: eyes open/closed on firm and foam surfaces. Testing is performed while standing on the RAPID foot pressure mat, which captures center of pressure and postural sway data. The primary measure is average sway area of the four sensory conditions. The sway area is the area which is required to correct equilibrium, representing the total area covered by postural sway, measured in square centimeters (cm²).
This test evaluates upper body muscular power. Participants perform a two-handed chest throw of a 2-kg medicine ball from a standing position. The MST is used to record throw distance, velocity, and related performance metrics. The primary measure is Peak Power Score (W).
This test assesses lower body strength and function. Participants are instructed to stand up from a chair and sit back down five times without using their arms. The MST measures movement dynamics. The primary measure is peak power score (W).
The 6MWT is a standardized submaximal exercise test used to assess functional aerobic capacity. Participants are instructed to walk as far as possible in six minutes along a flat, straight course. The total distance walked is recorded in feet. Longer walking distances indicate better aerobic capacity and endurance.
Participants are instructed to squeeze the dynamometer with maximum effort, measured in kilograms. The highest value from multiple trials is recorded.
The SF-12 is a standardized, self-administered questionnaire designed to assess overall health-related quality of life. It includes 12 items that measure physical and mental health components, generating Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores are standardized on a scale where higher values indicate better health status. Both PCS and MCS scores typically range from 0 to 100, with 0 indicating the poorest health and 100 indicating the best possible health status.
The PROMIS is a standardized set of self-reported questionnaires designed to measure health domains. This study includes the fatigue and physical function domains, which assess the participant's perceived level of tiredness and ability to perform daily physical activities. Responses generate standardized T-scores, calibrated to the general population. Higher fatigue T-scores indicate greater fatigue severity.
Study locations
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