Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medical Corps, Israel Defense Force.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT00918359
First received: June 10, 2009
Last updated: June 28, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: heller institute, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT00918359     History of Changes
Other Study ID Numbers: 782-2008-IDF-CTIL
Study First Received: June 10, 2009
Last Updated: June 28, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Disease Susceptibility
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014