Exercise Changes to Peripheral Blood Mononuclear Cells in Children - Full Text View

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00585403

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:

MedlinePlus related topics: Child Development Exercise and Physical Fitness Infant and Newborn Development Obesity Toddler Development

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:

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.
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).
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 February 09, 2012