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Exercise Changes to Peripheral Blood Mononuclear Cells in Children

This study is currently recruiting participants.
Verified November 2010 by University of California, Irvine
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585403
First received: December 26, 2007
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

The goal of this research is to determine how the peripheral immune system is altered by exercise and differences related to gender, pubertal status and health.


Condition
Physical Fitness
Obesity
Child Development
Growth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: PBMC, Exercise and Children: Initial Mechanisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Biospecimen Retention:   Samples With DNA

Peripheral blood mononuclear cells, plasma, serum, mRNA


Estimated Enrollment: 160
Study Start Date: September 2004
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
Early and late pubertal girls and boys

Detailed Description:

SPECIFIC AIMS:

  1. To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:

    1. Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
    2. PBMC gene regulation of stress, inflammatory, and growth/repair mediators [including: interleukin-4 (IL-4), IL-6, IL-10, tumor necrosis factor-alpha (TNF-alpha), interferon-gamma), growth hormone (GH), insulin-like growth factor-I (IGF-I), heat shock proteins (Hsp)].
    3. Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
    4. Circulating endogenous triggers of PBMC mediator responses—soluble Hsp, IL-6, and F2-isoprostanes.
  2. To determine how the acute PBMC responses are altered by gender, pubertal status, body composition (measured by whole-body and regional DEXA), and fitness (measured by progressive cycle ergometry and gas exchange).
  3. To determine the relationship in healthy children and adolescents among acute PBMC responses to exercise, biochemical precursors of the metabolic syndrome (insulin, glucose, lipids), and the balance of the TH1/TH2 immune response.
  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Early and late pubertal boys and girls recruited from Orange County, CA

Criteria

Inclusion Criteria:

  • appropriate Tanner Stage
  • No evidence of disease or disability

Exclusion Criteria:

  • no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
  • elite children participating in extensive exercise or dance programs
  • pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585403

Contacts
Contact: Lori D. Wilson, PhD 714-456-2246 lwilson@uci.edu

Locations
United States, California
General Clinical Research Center Recruiting
Orange, California, United States, 92868
Contact: Ruth Bundy, PhD     714-456-2317     rvbundy@uci.edu    
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Dan M Cooper, M.D. Univ. California, Irvine, CA
  More Information

No publications provided

Responsible Party: Dan M. Cooper, UC Irvine, Dept of Pediatrics
ClinicalTrials.gov Identifier: NCT00585403     History of Changes
Other Study ID Numbers: PBMC Exercise, HL-80947
Study First Received: December 26, 2007
Last Updated: November 5, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013