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Clinical Trials/NCT00108901
NCT00108901
Completed
Phase 2

Exercise Dose and Insulin Sensitivity in Obese Children

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 country222 target enrollmentJune 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obesity
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment
222
Locations
1
Primary Endpoint
Insulin area under the curve (oral glucose tolerance test)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
January 2007
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Insulin area under the curve (oral glucose tolerance test)

Time Frame: 10-15 weeks

Body composition (% body fat, visceral fat)

Time Frame: 10-15 weeks

Aerobic fitness

Time Frame: 10-15 weeks

Cognition (Executive function)

Time Frame: 10-15 weeks

Secondary Outcomes

  • 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)

Study Sites (1)

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