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Fitness Training in Children

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ClinicalTrials.gov Identifier: NCT00205296
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Obesity Low Fitness Behavioral: exercise

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Fitness Training on Insulin Sensitivity and Body Composition in Children
Study Start Date : March 2002
Primary Completion Date : December 2012
Study Completion Date : December 2012
Arms and Interventions

Intervention Details:
    Behavioral: exercise
    this will test the effect of exercise on insulin sensitivity, fitness and body composition

Outcome Measures

Primary Outcome Measures :
  1. maximal VO2 levels [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. fasting insulin and glucose levels [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obesity
  • low fitness

Exclusion Criteria:

  • diagnosis of diabetes
  • inability to exercise
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205296     History of Changes
Other Study ID Numbers: 2002-090
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2008

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs