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临床试验/NCT01316731
NCT01316731已完成不适用

Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Wageningen University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年2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
2
主要终点
Gene expression changes in skeletal muscle from baseline to after exercise

研究概览

简要总结

Rationale: Proteins released from muscle during and shortly after exercise, often referred to as myokines, may be central to our understanding of the cross-talk during and after exercise between skeletal muscles and other organs, in particular the liver. So far only a few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of these several known myokines in developing insulin resistance, revealing new putative myokines might provide valuable information and a direction for future research on the pathogenesis and treatment of type 2 diabetes mellitus.

Objective: The objective of the present study is to identify novel myokines, expression of which is altered in skeletal muscle after a single bout of exercise.

Study design: experimental study. Study population: Ten healthy, male subjects between 40 and 60 years of age and BMI < 30 kg/m2, will participate in this study.

Intervention: A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.

Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels of selected proteins after exercise.

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 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age 40-60 years
  • Male gender
  • BMI < 30 kg/m2

排除标准

  • Exercising regularly (> 2 times a week, > 3 hour in total per week)
  • Unstable body weight (weight gain or loss > 3 kg in the past three months)
  • Following, or have recently followed a (weight-loss) diet
  • Donated or intended to donate blood 2 months before until two months after the study
  • Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease)
  • Systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg
  • Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate).
  • Use of antithrombotic therapy (marcoumar, sintromitis).
  • Diagnosed diabetes mellitus type 1 or
  • Drugs or alcohol abuse ( > 3 glasses of alcoholic beverages a day).
  • (Chronic) injuries of the locomotor system that can interfere with the intervention
  • Participated in another study within the last six months

结局指标

主要结局

Gene expression changes in skeletal muscle from baseline to after exercise

时间窗: T = 0 and T =1

Gene expression is measured using whole genome Affymatrix microarrays Muscle tissue will be collected at time points T = 0 (before exercise) and T = 1 (directly after exercise). Special focus is on the changes in genes coding for myokines. Up to 5 genes will be selected for follow-up analysis.

Changes in plasma levels of selected proteins

时间窗: T = 0, T =1 and T = 3

Selected proteins will be analyzed by ELISA assays or western blot analysis, depending on ELISA availability at T = 0, T = 1 and T = 3 (2 hours post-exercise). The selection of the proteins is based on significance, the robustness of induction (\>80% of subjects showing induction) and the magnitude of the induction ( mean fold change \> 2)

次要结局

  • PBMC gene expression changes before and after exercise(T = 0, T = 1 and T =3)
  • Routine plasma level changes before and after exercise(T = 0, 1 and 3)
  • Heart rate changes, baseline compared with exercise(During the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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