An Exercise Intervention Study in Insulin-Resistant Adolescents

Study Overview
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Brief Summary
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Hypothesis: 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 two month supervised aerobic training.

Detailed Description
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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.

Official Title
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An Exercise Intervention in Insulin-Resistant Minority Adolescents

Conditions
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Insulin Resistance, Obesity

Intervention / Treatment
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* Procedure: Aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be between 14 to 18 years old Being African American or Hispanic Sedentary (exercising less than twice a week for less than 20 minutes) Non-smoker At high risk of developing insulin resistance BMI for age grater than or equal to the 95th percentile Exclusion Criteria: History of chronic illnesses Thyroid dysfunction Taking medications know to affect metabolism Being pregnant or lactating

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aerobic exercise<br>Aerobic exercise in Insulin Resistant Minority Adolescents | Procedure: Aerobic exercise<br>* A graded exercise stress test (GXT) will be done under cardiologist supervision. Subjects will undergo three month of supervised aerobic exercise.<br>* Other names: Exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity index |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of change in fibrinolytic markers |  | 6 month |