- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585403
Exercise Changes to Peripheral Blood Mononuclear Cells in Children
January 22, 2021 updated by: University of California, Irvine
PBMC, Exercise and Children: Initial Mechanisms
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.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
SPECIFIC AIMS:
To systematically measure for the first time in healthy children and adolescents the effects of brief bouts of exercise on:
- Numbers of circulating PMBCs, their subsets and key intercellular adhesion molecules (ICAMs).
- 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)].
- Circulating (serum) and intracellular PBMC levels of key mediators by flow cytometry and cell culture techniques.
- 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.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Orange, California, United States, 92868
- General Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Early and late pubertal boys and girls recruited from Orange County, CA
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children
Early and late pubertal girls and boys
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dan M Cooper, M.D., Univ. California, Irvine, CA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
December 26, 2007
First Posted (Estimate)
January 3, 2008
Study Record Updates
Last Update Posted (Actual)
January 25, 2021
Last Update Submitted That Met QC Criteria
January 22, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- PBMC Exercise [2004-3967]
- HL-80947
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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