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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00345436
Other study ID # 999906094
Secondary ID 06-CH-N094
Status Completed
Phase N/A
First received June 27, 2006
Last updated June 30, 2017
Start date February 8, 2006
Est. completion date May 11, 2011

Study information

Verified date May 11, 2011
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 11, 2011
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility - INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Childrens National Medical Center Washington, D.C. District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2003 Feb 28. — View Citation

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