Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Type 2 Diabetes Mellitus in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00073268
Recruitment Status : Completed
First Posted : November 19, 2003
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE November 18, 2003
First Posted Date  ICMJE November 19, 2003
Last Update Posted Date January 15, 2010
Study Start Date  ICMJE December 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Type 2 Diabetes Mellitus in Children
Official Title  ICMJE Prevention of Type 2 Diabetes Mellitus in Children
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Behavioral: Exercise
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
300
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Early adolescent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073268
Other Study ID Numbers  ICMJE 14239 (completed)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP