NCT07226947招募中不适用
BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Lean mass (kg)
研究概览
简要总结
The goal of this study is to learn if a smartwatch that measures activity level and body composition, combined with exercise reminders, can safely improve strength and muscle mass in people who recently started or are planning to start treatment with incretin therapy (liraglutide, semaglutide, tirzepatide or retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old at time of signing informed consent
- •Started treatment with incretin therapy (liraglutide, semaglutide, tirzepatide, or retatrutide) within the past 2 months or planning to start this treatment
- •a. Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment
- •Able to provide informed consent
排除标准
- •Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months
- •BMI <25 kg/m2 at the time of screening
- •Unable to participate in a regular physical exercise program
- •Implanted pacemaker
- •Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study
结局指标
主要结局
Lean mass (kg)
时间窗: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
次要结局
- Fat mass index (kg/m2)(6 months)
- Fat mass (kg)(6 months)
- Lean mass index (kg/m2)(6 months)
- Appendicular lean mass index (kg/m2)(6 months)
- Visceral adipose tissue (kg)(6 months)
- Lean mass/fat mass ratio(6 months)
- Fat free mass(6 months)
- Hand grip strength (kg)(6 months)
- 1-minute sit-to-stand(6 months)
- 6-minute walk test(6 months)
- Short Physical Performance Battery frailty score (total points)(6 months)
- Physical activity score(6 months)
研究者
Melissa Susan Putman
Principal Investigator
Massachusetts General Hospital
研究点 (2)
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