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Exercise Changes to Peripheral Blood Mononuclear Cells in Children

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ClinicalTrials.gov Identifier: NCT00585403
Recruitment Status : Unknown
Verified November 2010 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : January 3, 2008
Last Update Posted : November 8, 2010
Sponsor:
Information provided by:
University of California, Irvine

Brief Summary:
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 or disease
Physical Fitness Obesity Child Development Growth

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.

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: PBMC, Exercise and Children: Initial Mechanisms
Study Start Date : September 2004
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Children
Early and late pubertal girls and boys



Biospecimen Retention:   Samples With DNA
Peripheral blood mononuclear cells, plasma, serum, mRNA


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: November 8, 2010
Last Verified: November 2010