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Enrolling by invitation NCT07057310

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

Phase IV Interventional Obesity Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: semaglutide or tirzepatide, Lifestyle modification intervention.
Who it may be relevant to
Registry conditions: Obesity, Menopause. Basic parameters: 46 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug semaglutide or tirzepatide
    Semaglutide and tirzepatide will be dosed as per prescription labels
  • Behavioral 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 outcome measures

  • Physical Function Measure: Short Physical Performance Battery (SPPB) score. [Time frame: 24 weeks]
  • Physical Function Measure: Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) performed on the Rehabilitation Artificial Physical Intelligence Database (RAPID) foot pressure mat [Time frame: 24 weeks]
  • Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST) [Time frame: 24 weeks]
  • Physical Function Measure: Chair-to-Stand Tests using Motion Sensor Technology (MST) [Time frame: 24 weeks]
  • Physical Function Measure: Six-Minute Walk Test (6MWT) [Time frame: 24 weeks]
  • Physical Function Measure: Hand Grip Strength using a Hydraulic Hand Dynamometer [Time frame: 24 weeks]
  • Physical Function Measure: Short Form-12 (SF-12) Health Survey [Time frame: 24 weeks]
  • Physical Function Measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue and Physical Function Domains [Time frame: 24 weeks]
  • Aging Biomarkers: Cellular Senescence Markers in Plasma [Time frame: 24 weeks]
  • Difference between biological and chronological age [Time frame: 24 weeks]

Eligibility criteria

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)
  • Uncontrolled co-morbidities including inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, or psychiatric disease
  • >5% change in weight during the 3 months prior to screening
  • Other anti-obesity medication use within the past 3 months
  • History of bariatric surgery
  • History of malignant neoplasms within the past 5 years prior to screening
  • Current use of supplements known to affect weight
  • Personal or family history of medullary thyroid cancer.
  • Wheelchair bound
  • Vision loss

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT07057310 · 24-010834

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗