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临床试验/NCT03733743
NCT03733743已完成不适用

Day-night Rhythm in Muscle Metabolism of Prediabetic Subjects

Maastricht University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年7月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
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 prediabetic 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 disobedience of a normal day-night rhythm negatively influences 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 is under the influence of a day-night rhythm. In this study, the presence of a day-night rhythm in skeletal muscle energy metabolism (in particular mitochondrial function) of overweight prediabetic participants will be investigated. During this study, subjects will stay at the research unit for 44 hours, with standardized meals and sleeping time. Five muscle biopsies (v. lateralis) and frequent blood draws will be taken. In addition, indirect calorimetry measurements will be performed.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Standardized living protocol

Other

Subjects are kept at the research facility to adhere to a standardized living protocol, mimicking a normal daily living situation. During the study, multiple tests will be performed, including muscle biopsies, blood draws, MRS measurements and indirect calorimetry.

干预措施: Standardized living protocol (Other)

结局指标

主要结局

Day-night rhythm in skeletal muscle mitochondrial respiration

时间窗: measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00

O2-flux (pmol/mg/s) measured with high resolution respirometry

次要结局

  • Day-night rhythm in whole-body energy metabolism (energy expenditure)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in serum free fatty acids (FFA)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in whole-body energy metabolism (glucose oxidation)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle DNA involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm of in markers of normal day-night rhythm (melatonin)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in serum triglycerides(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in serum cholesterol(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Change in energy status of the heart between morning and evening(Measured on first study day 5:30 PM (duration 45 minutes), second study day 7:30 AM (duration 45 minutes))
  • Day-night rhythm in whole-body energy metabolism (fat oxidation)(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle protein levels of markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in serum glucose(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm in muscle DNA of markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm in muscle mRNA markers involved in molecular clock and mitochondrial metabolism.(measured on day two at 8:00, 13:00, 18:00, 23:00, 04:00)
  • Day-night rhythm of markers of normal day-night rhythm (cortisol)(measured on day two, every two hours for 24 hours beginning at 08:00)
  • Day-night rhythm of in markers of normal day-night rhythm (core body temperature)(measured continuously for 24 hours on day two)
  • Day-night rhythm in serum insulin(measured on day two, every two hours for 24 hours beginning at 08:00)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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