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WithdrawnNCT00585403Updated Jan 25, 2021

Exercise Changes to Peripheral Blood Mononuclear Cells in Children

An observational study in Physical Fitness, Obesity and Child Development, sponsored by University of California, Irvine. Withdrawn at 1 site in United States. Open to participants aged 8 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-25.

Sponsored by University of California, Irvine · Observational

Why this study was withdrawn
Nonapplicable clinical trial
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
0
Ages
8 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Physical Fitness
  • Obesity
  • Child Development
  • Growth
03

In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • appropriate Tanner Stage
  • No evidence of disease or disability

Exclusion criteria

Exclusion Criteria:

  • no use of antiinflammatory medications, alcohol, illegal drugs or bronchodilators
  • elite children participating in extensive exercise or dance programs
  • pregnant
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Children

    Early and late pubertal girls and boys

06

Study locations

1 site
  • General Clinical Research Center
    Orange, California 92868, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00585403
Lead sponsor
University of California, Irvine
Responsible party
Sponsor
First posted
Jan 3, 2008
Start date
Dec 2004
Primary completion
Dec 2004
Completion
Dec 2004
Last update
Jan 25, 2021

Study contacts

Dan M Cooper, M.D.
principal investigator · Univ. California, Irvine, CA

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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