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NCT00918359 Clinical Trial

Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

Gene Expression Clinical Trial

Official title:
Following Study: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00918359
Other study ID # 782-2008-IDF-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received June 10, 2009
Last updated June 28, 2011
Start date May 2009

Study information
Verified date June 2011
Source Medical Corps, Israel Defense Force
Contact Chen Makranz, Dr
Phone 03-7376584
Email chenma@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Heller Institute of Medical Research Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

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