An Exercise Intervention Study in Insulin-Resistant Adolescents (3290)
Recruitment status was Active, not recruiting
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||An Exercise Intervention in Insulin-Resistant Minority Adolescents|
- Insulin sensitivity index [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Levels of change in fibrinolytic markers [ Time Frame: 6 month ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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 Research Institute|