NCT00345436

Brief Summary

Insulin resistance, often accompanied by obesity, plays a major role in the development of type 2 diabetes. This phenomenon may be related with the fact that American adolescents are now becoming less physically active in early puberty, explaining the largely pubertal and post-pubertal onset of type 2 diabetes in adolescence. Although regular physical activity has been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and adolescents, the magnitude of exercise training-induced improvement in the risk factors for type 2 diabetes has been only recently studied in adults and studied very little in pediatric populations. It is clear that exercise, diet, and genetics all contribute to the development of type 2 diabetes in children. However, the few studies that have been done to dissect the relative contributions of these three risk factors have generally used only lipid profiles as the end point. There have been a number of recent advances in our understanding of the molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways modulated by exercise within muscle tissue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2011

Completed
Last Updated

July 2, 2017

Status Verified

May 11, 2011

First QC Date

June 27, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Insulin SensitivityModerate intensityInsulin ResistanceExercise Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • To be included in this study, subjects must meet the following conditions:
  • Sedentary (regular aerobic exercise less than or equal to 2 times/wk and less than 20 min/session): nonsmoker; impaired glucose tolerance (fasting plasma glucose greater than or equal to 100 mg/dl but less than 126 mg/dl or/and 2 hour plasma glucose greater than or equal to 140 mg/dl but less than 200 MG/dl; BMI-for-age is 95% or greater.

You may not qualify if:

  • Not pregnant; and not have any other medical condition that would preclude regular exercise.
  • If taking medication known to affect metabolism.
  • History of chronic illness known to affect metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

Related Publications (4)

  • Arslanian S, Suprasongsin C. Differences in the in vivo insulin secretion and sensitivity of healthy black versus white adolescents. J Pediatr. 1996 Sep;129(3):440-3. doi: 10.1016/s0022-3476(96)70078-1.

    PMID: 8804335BACKGROUND
  • Brown MD, Moore GE, Korytkowski MT, McCole SD, Hagberg JM. Improvement of insulin sensitivity by short-term exercise training in hypertensive African American women. Hypertension. 1997 Dec;30(6):1549-53. doi: 10.1161/01.hyp.30.6.1549.

    PMID: 9403581BACKGROUND
  • Hittel DS, Kraus WE, Hoffman EP. Skeletal muscle dictates the fibrinolytic state after exercise training in overweight men with characteristics of metabolic syndrome. J Physiol. 2003 Apr 15;548(Pt 2):401-10. doi: 10.1113/jphysiol.2002.036616. Epub 2003 Feb 28.

    PMID: 12611918BACKGROUND
  • Many G, Hurtado ME, Tanner C, Houmard J, Gordish-Dressman H, Park JJ, Uwaifo G, Kraus W, Hagberg J, Hoffman E. Moderate-intensity aerobic training program improves insulin sensitivity and inflammatory markers in a pilot study of morbidly obese minority teens. Pediatr Exerc Sci. 2013 Feb;25(1):12-26. doi: 10.1123/pes.25.1.12.

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 28, 2006

Study Start

February 8, 2006

Study Completion

May 11, 2011

Last Updated

July 2, 2017

Record last verified: 2011-05-11

Locations