An Exercise Intervention Study in Insulin-Resistant Adolescents (3290)

May 19, 2009 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

An Exercise Intervention in Insulin-Resistant Minority Adolescents

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Insulin-Resistant Minority Adolescents

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
aerobic exercise
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.

Other Names:
  • Exercise
  • Obesity
  • Insulin Resistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin sensitivity index
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of change in fibrinolytic markers
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Children's National Research Institute

Investigators

  • Principal Investigator: Eric P Hoffman, PHD, Children's National Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U10HD030447 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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