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Prevention of Type 2 Diabetes Mellitus in Children

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00073268
  Purpose

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Behavioral: Exercise
Phase I

MedlinePlus related topics:   Diabetes    Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Prevention of Type 2 Diabetes Mellitus in Children

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:   300
Study Start Date:   December 2002
Estimated Study Completion Date:   June 2007

  Eligibility
Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Early adolescent

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073268

Locations
United States, New York
New York Presbyterian Hospital    
      New York, New York, United States
Russ Berrie Pavilion    
      New York, New York, United States, 10032

Sponsors and Collaborators
  More Information


Study ID Numbers:   14239
First Received:   November 18, 2003
Last Updated:   December 6, 2007
ClinicalTrials.gov Identifier:   NCT00073268
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
diabetes  
adolescent  

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 20, 2008




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