Clinical Trials Directory

Trials / Completed

CompletedNCT00073268

Prevention of Type 2 Diabetes Mellitus in Children

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Sex
All
Age
12 Years – 15 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise

Timeline

Start date
2002-12-01
Completion
2007-06-01
First posted
2003-11-19
Last updated
2010-01-15

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00073268. Inclusion in this directory is not an endorsement.