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临床试验/NCT05139420
NCT05139420
进行中(未招募)
不适用

Biomarkers of Increased Risk of Developing Metabolic Adaptation to Weight Loss

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 60 人2022年9月10日

概览

阶段
不适用
干预措施
lifestyle intervention with meal replacement program
疾病 / 适应症
Weight Loss
发起方
Medical College of Wisconsin
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
状态
进行中(未招募)
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2022年9月10日
结束日期
2031年11月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Lisa Morselli, MD PhD

Assistant professor

Medical College of Wisconsin

入排标准

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

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

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)

研究点 (1)

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