Overview

This trial is active, not recruiting.

Conditions insulin resistance, obesity
Treatment aerobic exercise
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator Children's Research Institute
Start date March 2005
End date June 2009
Trial size 40 participants
Trial identifier NCT00906724, U10 HD 030447

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Aerobic exercise in Insulin Resistant Minority Adolescents
aerobic exercise Insulin Resistance
A graded exercise stress test (GXT) will be done under cardiologist supervision. Subjects will undergo three month of supervised aerobic exercise.

Primary Outcomes

Measure
Insulin sensitivity index
time frame: 6 month

Secondary Outcomes

Measure
Levels of change in fibrinolytic markers
time frame: 6 month

Eligibility Criteria

Male or female participants from 14 years up to 18 years old.

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

Additional Information

Official title An Exercise Intervention in Insulin-Resistant Minority Adolescents
Principal investigator Eric P Hoffman, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).