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Biomarker Analysis of Stress

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00527384
Collaborator
(none)
50
Enrollment
1
Location
43
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Time Perspective:
    Prospective
    Official Title:
    Biomarker Signatures of Biological, Chemical, or Psychological Stress
    Study Start Date :
    Oct 1, 2007
    Actual Primary Completion Date :
    May 1, 2011
    Actual Study Completion Date :
    May 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Patients at Wadsworth Center with Sepsis

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Wadsworth Center Albany New York United States 12201

      Sponsors and Collaborators

      • National Institute of Environmental Health Sciences (NIEHS)

      Investigators

      • Principal Investigator: David A. Lawrence, Ph.D., Wadsworth Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00527384
      Other Study ID Numbers:
      • 16014-CP-001
      First Posted:
      Sep 10, 2007
      Last Update Posted:
      Apr 14, 2015
      Last Verified:
      Apr 1, 2015
      Keywords provided by , ,
      Stress

      Study Results

      No Results Posted as of Apr 14, 2015