- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00918359
Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes
June 28, 2011 updated by: Medical Corps, Israel Defense Force
Following Study: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chen Makranz, Dr
- Phone Number: 03-7376584
- Email: chenma@sheba.health.gov.il
Study Locations
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Ramat Gan, Israel, 52621
- Recruiting
- Heller Institute of Medical Research
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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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
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.
Description
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 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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HI
Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Intolerance .
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HT
Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Tolerance .
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
May 1, 2009
Study Registration Dates
First Submitted
June 10, 2009
First Submitted That Met QC Criteria
June 10, 2009
First Posted (Estimate)
June 11, 2009
Study Record Updates
Last Update Posted (Estimate)
June 29, 2011
Last Update Submitted That Met QC Criteria
June 28, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 782-2008-IDF-CTIL
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.
Clinical Trials on Heat Intolerance
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University of ConnecticutUnited States Department of DefenseRecruitingHeat Intolerance | Heat Stress | Fatigue; HeatUnited States
-
Brigham Young UniversityRecruitingHigh Intensity Interval Training | Aging | Exercise Intolerance | Heat TherapyUnited States
-
Erasmus Medical CenterRecruitingHeat Illness | Heat Exhaustion | Heat Stroke ExertionalNetherlands
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Direction Centrale du Service de Santé des ArméesCompletedHeat Stress | HeatFrance
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Johns Hopkins UniversityAga Khan University; Aman FoundationCompletedHeat Illness | Heat | Heat Exposure | Heat Stroke | Heat Exhaustion | Heat Syncope, Sequela | Heat Collapse | Heat Stroke and SunstrokePakistan
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Petros DinasCompleted
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Petros DinasCompleted
-
Stanford UniversityCompleted
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University of OttawaRecruitingExercise | Core Temperature | Heat Stress, Exertional | Heat FatigueCanada