An Exercise Intervention Study in Insulin-Resistant Adolescents

• Conditions: Insulin Resistance; Obesity
• Interventions: Procedure: Aerobic exercise

• Registration Number: NCT00906724
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

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

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 Timeline

• Study Start: 2005-03
• Status Verified: 2009-01
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Last Update Submitted: 2009-05-19
• Study First Posted: 2009-05-21
• Last Update Posted: 2009-05-21
• Primary Completion: 2009-06
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aerobic exercise	Aerobic exercise	Aerobic exercise in Insulin Resistant Minority Adolescents

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity index	6 month

Secondary Outcome Measures

Name	Time	Method
Levels of change in fibrinolytic markers	6 month

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States