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Prevention of Type 2 Diabetes Mellitus in Children

Prevention of Type 2 Diabetes Mellitus in Children

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00073268
Enrollment
300
Registered
2003-11-19
Start date
2002-12-31
Completion date
2007-06-30
Last updated
2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes, adolescent

Brief 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.

Interventions

BEHAVIORALExercise

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

Early adolescent

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026