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Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Medical Corps, Israel Defense Force.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00918359
First Posted: June 11, 2009
Last Update Posted: June 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Corps, Israel Defense Force
  Purpose
Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat stroke (and possibly death) in a large number of military and civilian occupational groups. We have demonstrated malfunction of transcriptional pathways in the heat stressed HI phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals. Such differences are evident even under normothermic basal/comfort conditions. Heat and exercise challenges during the heat tolerance test (HTT) further emphasize the differences between the groups, particularly during recovery at comfort temperatures. Our results indicate that it may be possible to identify markers of heat intolerance. To achieve this goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene expression profiles using customized DNA microarrays and bioinformatic tools (the genes selected will be based on our previous DNA microarray studies). Lymphocyte samples collected from HT and HI individuals under resting/comfort conditions will be examined. Treatments and analyses are designed to reveal HI-associated gene-expression profiles (constitutive or inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat injury. The identification of such subjects could prevent unnecessary loss of life. Notably, the rapidly changing climate in our era increases the number of occupation/age groups in which manifestations of HI will appear.

Condition
Heat Intolerance Genotypic Variations Gene Expression Genomic Markers for Predisposition of Heat Intolerance

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Following Study: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

Further study details as provided by Medical Corps, Israel Defense Force:

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 50
Study Start Date: May 2009
Groups/Cohorts
HI
Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Intolerance .
HT
Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Tolerance .

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Blood samples of HT and HI subjects will be collected from volunteers who experienced heat exhaustion or heat stroke in their past and participating in heat tolerance test (HTT). The test, using conservative criteria discriminates between HI and HT groups. The distinction between HI and HT groups occurs only following analyses of the HTT.
Criteria

Inclusion Criteria:

  • Experienced heat exhaustion or heat stroke in their past
  • Participating in heat tolerance tests (HTT)

Exclusion Criteria:

  • Unambiguous result of the HTT
  • HTT stop by the subject decision
  Contacts and Locations
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): NCT00918359


Contacts
Contact: Chen Makranz, Dr 03-7376584 chenma@sheba.health.gov.il

Locations
Israel
Heller Institute of Medical Research Recruiting
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Medical Corps, Israel Defense Force
  More Information

Responsible Party: heller institute, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT00918359     History of Changes
Other Study ID Numbers: 782-2008-IDF-CTIL
First Submitted: June 10, 2009
First Posted: June 11, 2009
Last Update Posted: June 29, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Disease Susceptibility
Disease Attributes
Pathologic Processes