Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women

What this trial studies

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.

Conditions in scope

• Obesity
• Menopause

Interventions

• semaglutide or tirzepatide (Drug) — Semaglutide and tirzepatide will be dosed as per prescription labels
• Lifestyle modification intervention (Behavioral) — 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…

Who can join

Women only · Ages 46 Years to 60 Years

Inclusion criteria

• Postmenopausal women (with menopause defined as the cessation of menstrual periods for at least 12 months or history of bilateral oophorecomy)
• Age 46-60 years old
• BMI ≥ 30 kg/m2.

Exclusion criteria

• Past or current use of menopausal hormone therapy
• Early or premature menopause
• History of chemically induced menopause
• Impaired renal function (GFR ≤29)
• Thyroid-stimulating hormone ≥7 with low free T4
• Diabetes
• Cardiovascular disease
• Elevated blood pressure (\>170/\>95)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Enrolling by invitation
• Study type: Interventional
• Phase: PHASE4
• Start date: 2025-05-01
• Primary completion: 2026-12-31
• Last update posted: 2025-07-09
• First posted: 2025-07-09

Sponsor & contact

Lead sponsor: Mayo Clinic (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Physical Function Measure: Short Physical Performance Battery (SPPB) score. (24 weeks)
  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.
• Physical Function Measure: Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) performed on the Rehabilitation Artificial Physical Intelligence Database (RAPID) foot pressure mat (24 weeks)
  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…
• Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST) (24 weeks)
  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).
• Physical Function Measure: Chair-to-Stand Tests using Motion Sensor Technology (MST) (24 weeks)
  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).
• Physical Function Measure: Six-Minute Walk Test (6MWT) (24 weeks)
  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.

Related ClearedRx care

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