Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in measured and predicted resting metabolic rate during and after weight loss
研究概览
简要总结
This study aims at identifying the neurohormonal biomarkers that characterize individuals at risk of greater metabolic adaptation to weight loss, a disproportionate decline in resting metabolic rate during and after weight loss.
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
- •BMI > or = 30 any ethnicity
排除标准
- •weight > or = 400 lbs.
- •diabetes (type 2 or type 1)
- •hypertension
- •heart disease
- •kidney disease
- •liver disease
- •active cancer
- •post solid organ or bone marrow transplant
- •breastfeeding
- •current smoker
- •current recreational drug use
研究组 & 干预措施
lifestyle intervention
Participants will be enrolled in a weight loss program based on lifestyle changes. They will be given a 6-month subscription to a calorie-reduced meal replacement program that also offers lifestyle coaching.
干预措施: lifestyle intervention with meal replacement program (Other)
结局指标
主要结局
change in measured and predicted resting metabolic rate during and after weight loss
时间窗: 18 months
resting metabolic rate will be measured by indirect calorimetry every 2 months for 6 months, then every 6 months for an additional 12 month. Predicted resting metabolic rate will be calculated with a mathematical formula at the same time points
次要结局
- change in circulating thyroid hormones during and after weight loss(18 months)
- change in circulating AgRP during and after weight loss(18 months)
- change in heart rate variability during and after weight loss(18 months)
- change in circulating leptin during and after weight loss(18 months)
- change in circulating GLP-1 during and after weight loss(18 months)
- change in 24h urine catecholamines during and after weight loss(18 months)
- change in circulating PYY during and after weight loss(18 months)
研究者
Lisa Morselli, MD PhD
Assistant professor
Medical College of Wisconsin