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Prevention of Type 2 Diabetes Mellitus in Children
This study has been completed.
Study NCT00073268   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: November 18, 2003   Last Updated: December 6, 2007   History of Changes

November 18, 2003
December 6, 2007
December 2002
 
 
 
Complete list of historical versions of study NCT00073268 on ClinicalTrials.gov Archive Site
 
 
 
Prevention of Type 2 Diabetes Mellitus in Children
Prevention of Type 2 Diabetes Mellitus in Children

This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are:

  1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus.
  2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children.
  3. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.
 
Phase I
Interventional
Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study
Diabetes Mellitus, Type 2
Behavioral: Exercise
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
June 2007
 

Early adolescent

Both
12 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00073268
 
14239
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP