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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Children's Research Institute
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00906724
First received: May 19, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Insulin Resistance
Obesity
Procedure: Aerobic exercise

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Exercise Intervention in Insulin-Resistant Minority Adolescents

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Insulin sensitivity index [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Levels of change in fibrinolytic markers [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Insulin Resistance
  • Obesity
  • Exercise

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Insulin-Resistant Minority Adolescents

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906724

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Eric P Hoffman, PHD Children's Research Institute
  More Information

No publications provided

Responsible Party: Eric Paul Hoffman, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00906724     History of Changes
Other Study ID Numbers: U10 HD 030447
Study First Received: May 19, 2009
Last Updated: May 19, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014