Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 5:22 PM
Study NCT ID:
NCT03194035
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammation in an Ultra Endurance Race
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-10-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Per and post-exertional variations of IL1 during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of IL1 blood level'}, {'measure': 'Per and post-exertional variations of IL6 during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of IL6 blood level'}, {'measure': 'Per and post-exertional variations of TNF alpha during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of TNF alpha blood level'}, {'measure': 'Per and post-exertional variations of HMG beta during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of HMG beta blood level'}, {'measure': 'Per and post-exertional variations of CRP during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of CRP blood level'}, {'measure': 'Per and post-exertional variations of IL4 during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of IL4 blood level'}, {'measure': 'Per and post-exertional variations of IL10 during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of IL10 blood level'}, {'measure': 'Per and post-exertional variations of IL13 during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of IL13 blood level'}, {'measure': 'Per and post-exertional variations of lipids during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of lipids blood level'}, {'measure': 'Per and post-exertional variations of LPS during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of LPS blood level'}, {'measure': 'Per and post-exertional variations of lipoprotein during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of lipoprotein blood level'}, {'measure': 'Per and post-exertional variations of TGF beta during an ultra-endurance race in healthy volunteers.', 'timeFrame': 'Change measures : departure, 15, 50, 65, 90, 130 and 165 kilometers then at day 1 and 2 after the completion of the race', 'description': 'In this study, the investigators will measure variations of TGF beta blood level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation', 'exercise', 'ultra endurance'], 'conditions': ['Inflammation', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to study the per and post-exertional variations of the pro and anti inflammatory markers during an ultra-endurance race in healthy volunteers.', 'detailedDescription': 'Study per and post-exertional changes in proinflammatory biological (IL1, IL6, TNF alpha, HMG beta1 and CRP) and anti inflammatory parameters (IL4, IL10 and IL13, TGF beta, LPS, lipoproteins, lipids) during an ultra endurance race.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 healthy adult volunteers amateurly participating in the "100 miles South of France 2017 race ©" recruited electronically using an announcement on the race website.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male older than 18 years,\n2. Completion of an ultra-endurance race (distance greater than 50 kilometers) during the 24 months preceding the race.\n3. Affiliation or beneficiary of a social security.\n\nExclusion Criteria:\n\n1. Age lower than 18 years,\n2. Subjects with a medical history (pulmonary pathology, cardiac, hypertension) or with a significant chronic inflammatory disease observed during the inclusion visit (the day before the race).\n3. Female.'}, 'identificationModule': {'nctId': 'NCT03194035', 'acronym': 'TRAIL-INFLA', 'briefTitle': 'Inflammation in an Ultra Endurance Race', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Necker-Enfants Malades'}, 'officialTitle': 'Per Effort Study of Inflammatory Consequences of an Ultra Endurance Race (165km)', 'orgStudyIdInfo': {'id': 'TRAIL-INFLA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'Study per and post-exertional changes in proinflammatory biological (IL1, IL6, TNF alpha, HMG beta1 and CRP) and anti inflammatory parameters (IL4, IL10 and IL13, TGF beta, LPS, lipoproteins, lipids) during an ultra endurance race.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Necker-Enfants Malades', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Romain Jouffroy', 'investigatorAffiliation': 'Hôpital Necker-Enfants Malades'}}}}