GLP-1RA Effects on Lean Mass and Bone Health in Midlife Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This study is designed with the interest to learn on the effects of estrogen levels and how it affects body compositions and muscle function in midlife women who are taking a GLP-1RA for weight loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 35-60 year
- •BMI≥30 or BMI≥27 and at least one cardiometabolic risk factor (dyslipidemia, hypertension, obstructive sleep apnea, metabolic syndrome, fatty liver, PCOS)
- •Newly prescribed a GLP-1RA medication
- •English speaking
- •Body weight stable for the past 6 months
排除标准
- •Pregnant women
- •Under age 35 or over age 60
- •Born male
- •Cannot consent for themselves
- •Cannot read and speak in English
- •Type 2 diabetes
- •Recently discontinued a GLP-1RA medication (less than 6-months since discontinuing)
- •Contraindications for taking a GLP-1 RA medication (personal or family history of medullary thyroid carcinoma, personal or family history of multiple endocrine neoplasia type 2, personal history of pancreatitis, pregnancy, hypersensitivity to the drug or any component of the drug, active suicidal ideation)
- •Currently taking aromatase inhibitors or selective estrogen receptor modulators (SERMs)
研究组 & 干预措施
GLOW Participants
New patients, those who are newly prescribed a GLP-1RA medication will be invited to participate in the study where different measurements will be completed to assess body composition, hormone levels, muscle strength and nutrition.
结局指标
主要结局
Body weight
时间窗: Baseline through 6-month visit
Assess changes in body weight by measuring weight on a calibrated scale
Body composition
时间窗: Baseline through 6-month visit
Assess changes in lean and fat mass and fat-free mass in kilograms by total body DXA scan
Bone mineral density (BMD)
时间窗: Baseline through 6-month visit
Assess changes in bone mineral density (BMD) by completing femur DXA scans
Muscle function
时间窗: Baseline through 6-month visit
Assess muscle function changes in pounds by completing Grip strength tests
次要结局
- Estrogen level role in BMD changes during GLP-1RA therapy(Baseline through 6-month visit)
- Estrogen level role in muscle function changes during GLP-1RA therapy(Baseline through 6-month visit)
- Diet intake(Baseline through 6-month visit)
- Diet quality(Baseline through 6-month visit)