Prevention of Type 2 Diabetes Mellitus in Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00073268
First received: November 18, 2003
Last updated: January 14, 2010
Last verified: January 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Prevention of Type 2 Diabetes Mellitus in Children

Resource links provided by NLM:


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
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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

No publications provided

ClinicalTrials.gov Identifier: NCT00073268     History of Changes
Other Study ID Numbers: 14239 (completed)
Study First Received: November 18, 2003
Last Updated: January 14, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014