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An Exercise Intervention Study in Insulin-Resistant Adolescents

An Exercise Intervention in Insulin-Resistant Minority Adolescents

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00906724
Acronym
3290
Enrollment
40
Registered
2009-05-21
Start date
2005-03-31
Completion date
2009-12-31
Last updated
2009-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

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.

Interventions

PROCEDUREAerobic exercise

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

Sponsors

Children's National Research Institute
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Insulin sensitivity index6 month

Secondary

MeasureTime frame
Levels of change in fibrinolytic markers6 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026