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Fitness Training in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205296
First received: September 12, 2005
Last updated: October 29, 2008
Last verified: October 2008
History of Changes
  Purpose

We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week.


Condition Intervention
Obesity
Low Fitness
 Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • maximal VO2 levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting insulin and glucose levels [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2002
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: exercise
    this will test the effect of exercise on insulin sensitivity, fitness and body composition
  Eligibility

Ages Eligible for Study:   7 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obesity
  • low fitness

Exclusion Criteria:

  • diagnosis of diabetes
  • inability to exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205296

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Aaron Carrel, MD, MPH University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: Aaron Carrel, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00205296     History of Changes
Other Study ID Numbers: 2002-090
Study First Received: September 12, 2005
Last Updated: October 29, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013