Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT00918359
Status:
UNKNOWN
Last Update Posted:
2011-06-29
First Post:
2009-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-28', 'studyFirstSubmitDate': '2009-06-10', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Heat Intolerance', 'Genotypic Variations', 'Gene Expression', 'Genomic Markers for Predisposition of Heat Intolerance']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced heat exhaustion or heat stroke in their past\n* Participating in heat tolerance tests (HTT)\n\nExclusion Criteria:\n\n* Unambiguous result of the HTT\n* HTT stop by the subject decision'}, 'identificationModule': {'nctId': 'NCT00918359', 'briefTitle': 'Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes', 'organization': {'class': 'OTHER', 'fullName': 'Medical Corps, Israel Defense Force'}, 'officialTitle': 'Following Study: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes', 'orgStudyIdInfo': {'id': '782-2008-IDF-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HI', 'description': 'Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Intolerance .'}, {'label': 'HT', 'description': 'Subjects who experienced heat exhaustion or heat stroke in their past and will be identified by heat tolerance test (HTT) as Heat Tolerance .'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Heller Institute of Medical Research', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Chen Makranz, Dr', 'role': 'CONTACT', 'email': 'chenma@sheba.health.gov.il', 'phone': '03-7376584'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Corps, Israel Defense Force', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'heller institute', 'oldOrganization': 'Medical Corps, Israel Defense Force'}}}}