We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fitness Training in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205296
First Posted: September 20, 2005
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
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

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

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

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

Enrollment: 300
Study Start Date: March 2002
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: October 2, 2015
Last Verified: October 2008

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