An Exercise Intervention Study in Insulin-Resistant Adolescents (3290)
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|ClinicalTrials.gov Identifier: NCT00906724|
Recruitment Status : Unknown
Verified January 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was: Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : May 21, 2009
|Condition or disease||Intervention/treatment|
|Insulin Resistance Obesity||Procedure: Aerobic exercise|
The specific aims of the study are 1) To determine the effects of exercise on insulin sensitivity in insulin-resistant African-American and Hispanic adolescents; 2) To determine the effects of exercise on fibrinolytic markers in insulin-resistant African-American and Hispanic adolescents.
The hypothesis is that insulin-resistant African-American and Hispanic adolescents will show significant improvement of insulin sensitivity (SI) and positive changes associated with fibrinolytic markers and lipid profile after a 1 month pre-training period and two-months of supervised, moderate intensity aerobic exercise.
Part I. Insulin-resistant African American and Hispanic adolescents from the DC metro area will be recruited through various recruitment efforts. Potential participants will have 2 screening visits in which their medical history, physical activity level, body mass index, and fasting plasma glucose and insulin or OGTT results will determine eligibility.
Part 2. If inclusion criteria is met, the subjects will undergo a 2 week dietary stabilization period, treadmill exercise testing, IVGTT, blood draws for fibrinolytic and lipid markers, DEXA scan, and anthropometric measurements. Subjects will have a 1 month pre-training period and 2 months of supervised, moderate intensity aerobic exercise. All baseline testing will be repeated after the exercise period to see any significant differences.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||An Exercise Intervention in Insulin-Resistant Minority Adolescents|
|Study Start Date :||March 2005|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||December 2009|
Aerobic exercise in Insulin Resistant Minority Adolescents
Procedure: Aerobic exercise
A graded exercise stress test (GXT) will be done under cardiologist supervision.
Subjects will undergo three month of supervised aerobic exercise.
- Insulin sensitivity index [ Time Frame: 6 month ]
- Levels of change in fibrinolytic markers [ Time Frame: 6 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906724
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Eric P Hoffman, PHD||Children's National Research Institute|