Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Physical Function Measure: Short Physical Performance Battery (SPPB) score.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 46 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
Standard lifestyle intervention only
Subjects will receive standard of care lifestyle intervention only.
干预措施: Lifestyle modification intervention (Behavioral)
Weight loss medication and standard lifestyle intervention
Subjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention.
干预措施: semaglutide or tirzepatide (Drug)
Weight loss medication and standard lifestyle intervention
Subjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention.
干预措施: Lifestyle modification intervention (Behavioral)
结局指标
主要结局
Physical Function Measure: Short Physical Performance Battery (SPPB) score.
时间窗: 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
时间窗: 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 the total area covered by postural sway, measured in square centimeters (cm²).
Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Physical Function Measure: Hand Grip Strength using a Hydraulic Hand Dynamometer
时间窗: 24 weeks
Participants are instructed to squeeze the dynamometer with maximum effort, measured in kilograms. The highest value from multiple trials is recorded.
Physical Function Measure: Short Form-12 (SF-12) Health Survey
时间窗: 24 weeks
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.
Physical Function Measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue and Physical Function Domains
时间窗: 24 weeks
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.
Aging Biomarkers: Cellular Senescence Markers in Plasma
时间窗: 24 weeks
Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence.
Difference between biological and chronological age
时间窗: 24 weeks
Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years.
Vascular Function Assessment: Reactive Hyperemia Index (RHI) using EndoPAT
时间窗: 24 weeks
The RHI is measured using the EndoPAT device, which assesses endothelial function by evaluating changes in digital pulse volume during reactive hyperemia. This non-invasive test involves occluding blood flow in one arm followed by release to induce vasodilation, with pulse amplitude recorded via finger probes. Lower RHI values suggest endothelial dysfunction and increased cardiovascular risk.
次要结局
未报告次要终点
研究者
Maria Daniela Hurtado Andrade
Principal Investigator
Mayo Clinic
