ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Prevention of Type 2 Diabetes Mellitus in Children

This study is currently recruiting patients.

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)

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 Treatment or Intervention Phase
Diabetes Mellitus, Type 2
 Behavior: Exercise
Phase I

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study

Further Study Details: 

Expected Total Enrollment:  300

Study start: December 2002;  Study completion: June 2007

Eligibility

Ages Eligible for Study:  12 Years   -   15 Years,  Genders Eligible for Study:  Both

Criteria

Early adolescent

Location and Contact Information


New York
      New York Presbyterian Hospital, New York,  New York,  United States; Recruiting
Michael Rosenbaum, MD  212-769-3070    mr475@columbia.edu 
Michael Rosenbaum, MD,  Principal Investigator

      Russ Berrie Pavilion, New York,  New York,  10032,  United States; Recruiting
Michael Rosenbaum   mr475@columbia.edu 

More Information

Study ID Numbers:  14239
Record last reviewed:  June 2004
Record first received:  November 18, 2003
ClinicalTrials.gov Identifier:  NCT00073268
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act