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临床试验/NCT02261168
NCT02261168已完成不适用

Day-night Rhythm in Human Skeletal Muscle Metabolism

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Day-night rhythm in skeletal muscle mitochondrial respiration

研究概览

简要总结

This study evaluates the existence of a day-night rhythm in skeletal muscle energy metabolism in healthy lean subjects. Subjects will stay at the research facility for 44 hours with a standardized living protocol during which several measurements of skeletal muscle and whole body energy metabolism will be performed.

详细描述

Recent evidence from both observational and experimental studies indicates that disobeying our normal day-night rhythm negatively influences our metabolic and cardiovascular health, possibly leading to obesity and type 2 diabetes mellitus (T2DM). An important hallmark of obesity and T2DM is a decreased skeletal muscle mitochondrial function. Interestingly, recent research indicates that also skeletal muscle mitochondrial function under the influence of a day-night rhythm. The main objective of this study is to investigate the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of healthy young participants. Therefore, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. During this period we will take five muscle biopsies, perform indirect calorimetry measurements and blood draws.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Caucasian
  • Healthy (as determined by dependent physician based on medical questionnaire)
  • Age: 18-35 years
  • Normal BMI (18-25 kg/m2)
  • Regular sleeping time (normally 7-9h daily)

排除标准

  • Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
  • Heavily varying sleep-wake rhythm
  • Shiftwork during last 3 months
  • Travel across >1 time zone in the last 3 months
  • Engagement in exercise > 2 hours total per week
  • Using >400mg caffeine daily
  • Unstable body weight (weight gain or loss > 3kg in the last 3 months)
  • Significant food allergies/intolerance (seriously hampering study meals)
  • Participation in another biomedical study within 1 month before the first study visit
  • Any contra-indication to Magnetic Resonance Imaging (MRI) scanning

结局指标

主要结局

Day-night rhythm in skeletal muscle mitochondrial respiration

时间窗: 40 hours.

O2-flux (pmol/mg/s) measured with high resolution respirometry upon administration of different substrates

次要结局

  • Day-night rhythm in whole-body energy metabolism(40 hours.)
  • Day-night rhythm of in markers of normal day-night rhythm (cortisol, melatonin, core body temperature)(measured during the 2nd study day)
  • Day-night rhythm in muscle DNA, mRNA and protein levels of markers involved in molecular clock and mitochondrial metabolism.(40 hours.)
  • Change in liver volume and liver lipid concentration during the day(First study day 6 PM, second study day 7 AM)
  • Day-night rhythm in blood metabolic compounds (e.g. glucose, insulin, FFA's, cholesterol)(measured during the 2nd study day)
  • Day-night rhythm of molecular clock mRNA and protein levels in blood PBMC's(measured during the 2nd study day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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