Clinical Trials Directory

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UnknownNCT00906724

An Exercise Intervention Study in Insulin-Resistant Adolescents

An Exercise Intervention in Insulin-Resistant Minority Adolescents

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
All
Age
14 Years – 18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREAerobic exerciseA graded exercise stress test (GXT) will be done under cardiologist supervision. Subjects will undergo three month of supervised aerobic exercise.

Timeline

Start date
2005-03-01
Primary completion
2009-06-01
Completion
2009-12-01
First posted
2009-05-21
Last updated
2009-05-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00906724. Inclusion in this directory is not an endorsement.