Weight Changes After Incretin-mimetics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- weight change
研究概览
简要总结
The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?
详细描述
This study will enroll people who are taking an injectable weight loss drug, have lost weight with the help of this drug, and are required by their health insurance plan to discontinue treatment. Participants will first be screened for health conditions that would prevent them from entering the study. Once enrolled, participants will be asked to have the following testing while still on the injectable weight loss drug: body weight measurement, body composition (fat and lean mass), resting energy expenditure (calories burned), multiple blood draws after overnight fast and after drinking and nutritional shake urine collection, urine collection, measurement of heart rate, measurement of physical activity and sleep, questionnaires. Participants will then stop taking the injectable weight loss drug when the prescription runs out, and the same tests will be repeated 3 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 years or older
- •men and women
- •prescribed an incretin-mimetic for weight loss and for whom insurance coverage for this specific drug will lapse
- •any ethnicity
排除标准
- •weight > or = 400 lb
- •type 1 or type 2 diabetes
- •patients taking steroid medications
- •heart disease
- •advanced kidney disease (CKD stage 4 and 5)
- •decompensated liver disease
- •hyperthyroidism
- •untreated hypothyroidism
- •active cancer
- •post solid organ or bone marrow transplant
- •pregnancy/plan for pregnancy in the next 6 months
- •breastfeeding
- •post-menopausal women
- •current smoker
- •current recreational drug use
- •night shift or rotating shift workers
研究组 & 干预措施
incretin mimetic discontinuation
This study will enroll people who are taking an injectable weight loss drug, have lost weight with the help of this drug, and are required by their health insurance plan to discontinue treatment. They will be studied right before their medication runs out, and 3 months later
干预措施: discontinuation of weight loss medication (Other)
结局指标
主要结局
weight change
时间窗: 3 months
weight trajectories in the 3 months after treatment discontinuation
fasting and post-prandial circulating AgRP
时间窗: 3 months
Circulating AgRP will be measured after an overnight fast and during a 3-hour mixed meal test, at baseline (while still on injectable weight loss drug) and 3 months later. The mixed meal will consist in a nutrtional shake consumed in 5 min.
次要结局
- subjective hunger ratings(3 months)
- resting metabolic rate (RMR)(3 months)
- RMR adaptation(3 months)
- body composition(3 months)
研究者
Lisa Morselli, MD PhD
Assistant Professor
Medical College of Wisconsin