An Exercise Intervention Study in Insulin-Resistant Adolescents

NCT ID: NCT00906724

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-12-31

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.

Conditions

Insulin Resistance; Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

aerobic exercise

Aerobic exercise in Insulin Resistant Minority Adolescents

Aerobic exercise

Intervention Type: PROCEDURE

A graded exercise stress test (GXT) will be done under cardiologist supervision.

Subjects will undergo three month of supervised aerobic exercise.

Interventions

Aerobic exercise

A graded exercise stress test (GXT) will be done under cardiologist supervision.

Subjects will undergo three month of supervised aerobic exercise.

Intervention Type: PROCEDURE

Other Intervention Names

Insulin Resistance; Obesity; Exercise

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Responsible Party

Children's National Medical Center

Principal Investigators

Eric P Hoffman, PHD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

U10HD030447

Identifier Type: NIH

Identifier Source: org_study_id

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