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临床试验/NCT01828229
NCT01828229已完成不适用

Consequences of Human Inactivity

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年1月1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
50
试验地点
1
主要终点
Insulin sensitivity

研究概览

简要总结

Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.

The present protocol is divided in several in several sub-studies:

  1. To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
  2. To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
  3. To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal physical active
  • •18-40 y of age
  • •Non-smokers

排除标准

  • •Pregnancy
  • •Diabetes in family

研究组 & 干预措施

female inactivity and hypercaloric diet

Experimental

inactivity and hypercaloric diet in women for two weeks

干预措施: female inactivity and hypercaloric diet (Behavioral)

inactivity

Experimental

Inactivity for two weeks

干预措施: inactivity (Behavioral)

inactivity and hypercaloric diet

Experimental

inactivity and hypercaloric diet for two weeks

干预措施: inactivity and hypercaloric diet (Behavioral)

normal activity and hypercaloric diet

Experimental

Normal activity and hypercaloric diet for two weeks

干预措施: normal activity and hypercaloric diet (Behavioral)

inactivity and iso-caloric diet

Active Comparator

inactivity and iso-caloric diet for two weeks

干预措施: inactivity and iso-caloric diet (Behavioral)

结局指标

主要结局

Insulin sensitivity

时间窗: 2 weeks

Area under the curve of plasma glucose and insulin levels during an oral glucose tolerance test

次要结局

  • visceral adiposity(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Rasmussen Rinnov

Administrator

Rigshospitalet, Denmark

研究点 (1)

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