NCT00073268

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2003

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

First QC Date

November 18, 2003

Last Update Submit

January 14, 2010

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetesadolescent

Interventions

ExerciseBEHAVIORAL

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Early adolescent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Russ Berrie Pavilion

New York, New York, 10032, United States

Location

New York Presbyterian Hospital

New York, New York, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

November 18, 2003

First Posted

November 19, 2003

Study Start

December 1, 2002

Study Completion

June 1, 2007

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(2)