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临床试验/NCT00108901
NCT00108901已完成2 期

Exercise Dose and Insulin Sensitivity in Obese Children

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2003年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
222
试验地点
2
主要终点
Insulin area under the curve (oral glucose tolerance test)

研究概览

简要总结

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on risk for type 2 diabetes, fatness, fitness, blood cholesterol levels, and other cardiovascular risk factors in overweight elementary schoolchildren.

The hypothesis is that the more exercise a child does, the more benefit he or she will gain in reducing the risk of diabetes and other cardiovascular diseases.

An ancillary study examined effects on cognition and achievement.

详细描述

The study is a behavioral clinical trial of aerobic exercise to determine dose-response effects on insulin response to the oral glucose tolerance test, body composition, fitness, lipid profile, inflammation and other metabolic syndrome components in overweight elementary schoolchildren.

Blinded psychological assessments of cognition and achievement were obtained.

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
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Overweight, sedentary children
  • Black or white race
  • Attending specific schools in Augusta, GA area from which this study is recruiting

排除标准

  • Unable to participate in testing or vigorous exercise program
  • Taking medication that would affect study results
  • Sibling enrolled in project

结局指标

主要结局

Insulin area under the curve (oral glucose tolerance test)

时间窗: 10-15 weeks

Body composition (% body fat, visceral fat)

时间窗: 10-15 weeks

Aerobic fitness

时间窗: 10-15 weeks

Cognition (Executive function)

时间窗: 10-15 weeks

次要结局

  • Glucose (oral glucose tolerance test)(10-15 weeks)
  • Inflammation (C-reactive protein, fibrinogen)(10-15 weeks)
  • Lipid profile(10-15 weeks)
  • Blood pressure(10-15 weeks)
  • Academic achievement(10-15 weeks)

研究者

研究点 (2)

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