An Exercise Intervention Study in Insulin-Resistant Adolescents

NCT00906724 | Unknown DMC

• 1 other identifier: U10HD030447
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Obesity

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity index

  6 month

Secondary Outcomes (1)

• Levels of change in fibrinolytic markers

  6 month

Study Arms (1)

aerobic exercise

Aerobic exercise in Insulin Resistant Minority Adolescents

Procedure: Aerobic exercise

Interventions

Aerobic exercise PROCEDURE

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

Also known as: Insulin Resistance, Obesity, Exercise

aerobic exercise

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Insulin-Resistant Minority Adolescents

You may qualify if:

• 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

You may not qualify if:

• History of chronic illnesses
• Thyroid dysfunction
• Taking medications know to affect metabolism
• Being pregnant or lactating

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Children's National Research Institute: collaborator

Study Sites (1)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Obesity

Interventions

Exercise; insulin resistance factor (uremia); Adiposity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Eric P Hoffman, PHD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: March 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 21, 2009

Record last verified: 2009-01

Locations

US (1)