Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-01 @ 3:39 PM
Study NCT ID:
NCT04157556
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Maximal Exercise on MMP9 and TIMP1 and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are 2 groups in the study: Athletes and sedentary people.They will apply the same acute exercise protocol (The Yo-Yo Intermittent Recovery Test Level 1). A blood test will conduct before and after the acute exercise protocol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-28', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of MMP9 and TIMP1', 'timeFrame': 'Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)', 'description': 'The effect of acute maximal exercise on serum MMP9 and TIMP1 levels in athletes and sedentary people.'}, {'measure': 'MMP9 -1562 C/T, TIMP1 372 T/C polymorphisms', 'timeFrame': 'Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)', 'description': 'The role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on the effect of acute maximal exercise on serum MMP9 and TIMP1 in athletes and sedentary people.'}], 'secondaryOutcomes': [{'measure': 'Level of indicators of muscle damage and inflammation and oxidative stress', 'timeFrame': 'Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)', 'description': 'The relationship between primary outcome measures and indicators of muscle damage, inflammation and oxidative stress.\n\nIndicators to be determined: creatine kinase (CK), aspartate aminotransferase (AST), alanine aminotransferase (ALT), Interleukin-6 (IL-6), C- reactive protein (CRP), total antioxidant status (TAS), total oxidant status (TOS), nitric oxide (NO)'}, {'measure': 'Level of blood lipids and lipoproteins, glucose, urea, creatinine, hemogram', 'timeFrame': 'Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)', 'description': 'The relationship between primary outcome measures and blood lipids and lipoproteins, glucose, urea, creatinine and hemogram'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MMP9', 'TIMP1', 'MMP9 -1562 C/T', 'TIMP1 372 T/C']}, 'descriptionModule': {'briefSummary': 'Matrix metalloproteinases (MMPs) play a critical role in the remodeling and regeneration of skeletal muscle. Studies which investigate exercise and effects of MMPs and tissue inhibitors of matrix metalloproteinases (TIMPs) are contradictory. Also the role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on exercise are unclear. In accordance with this conditions the hypothesis of the study are as follows:\n\n1. Levels of basal serum MMP9 and TIMP1 are different between athletes (volleyball, basketball, handball) and sedentary people.\n2. Levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people .\n3. Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people.\n4. Levels of basal serum MMP9 and TIMP1 are related to MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms.\n5. Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise and MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms are different between athletes (volleyball, basketball, handball) and sedentary people.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup of athletes:\n\n* Male basketball players who have been training regularly for at least last 3 months.\n* Male volleyball players who have been training regularly for at least last 3 months.\n* Male handball players who have been training regularly for at least last 3 months.\n\nGroup of sedentary people:\n\n* Male individuals with similar physical characteristics to the group of athletes\n* Male individuals who have not exercise regularly for at least last 3 months.\n\nExclusion Criteria(For two groups):\n\n* Smoking regularly\n* Drinking alcohol regularly\n* Using drug and antioxidant substance\n* Being obese,\n* Being sick or having disability'}, 'identificationModule': {'nctId': 'NCT04157556', 'briefTitle': 'The Effect of Maximal Exercise on MMP9 and TIMP1 and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'The Effect of Maximal Exercise on Matrix Metalloproteinase Enzyme and Its Inhibitor (MMP9 and TIMP1) and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms', 'orgStudyIdInfo': {'id': '18-7.1/49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group of athletes', 'description': 'Age: 18-35 Gender: Male Basketball, volleyball, handball players who have been training regularly for at least last 3 months.', 'interventionNames': ['Other: Yo-Yo Intermittent Recovery Test Level 1']}, {'type': 'EXPERIMENTAL', 'label': 'Group of sedentary people', 'description': 'Age: 18-35 Gender: Male Individuals with similar physical characteristics to the group of athletes and who have not exercise regularly for at least last 3 months.', 'interventionNames': ['Other: Yo-Yo Intermittent Recovery Test Level 1']}], 'interventions': [{'name': 'Yo-Yo Intermittent Recovery Test Level 1', 'type': 'OTHER', 'description': 'The test is a standard test battery with progressively increasing speeds. After every 40-m run (2x20 m), active rest is performed by walking or jogging at a distance of 10 m (2x5 m). for 10 seconds. Participants are trying to adjust their speed according to incoming audio signals.The test is terminated when the participants can not reach the signal twice. The test ends in 10-20 minutes depending on the level of participants.\n\nReference Bangsbo, J., Iaia, F. M., \\& Krustrup, P. (2008). The Yo-Yo intermittent recovery test. Sports medicine, 38(1), 37-51.\n\nKrustrup, P., Mohr, M., Amstrup, T., Rysgaard, T., Johansen, J., Steensberg, A., ... \\& Bangsbo, J. (2003). The yo-yo intermittent recovery test: physiological response, reliability, and validity. Medicine \\& Science in Sports \\& Exercise, 35(4), 697-705.', 'armGroupLabels': ['Group of athletes', 'Group of sedentary people']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University Faculty of Sports Science', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Faruk Turgay, associate professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ege University, Faculty of Sports Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ege University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research assistant', 'investigatorFullName': 'Merve Koca Kosova', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}