Ignite Creation Date:
2025-12-25 @ 4:45 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT03563118
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-19', 'studyFirstSubmitDate': '2018-06-07', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prolidase activity', 'timeFrame': '1 month', 'description': 'Prolidase activity was determined by a photometric method based on the measurement of the proline levels produced by prolidase (26). Plasma samples (100ml) were blended with 100 ml of serum physiological. A total of 25 ml of the mixture was preincubated with 75ml of the preincubation solution (50 mmol/l Tris HCl buffer pH 7.0 containing 1mmol/l glutathion, 50mmol/l MnCl2) at 37˚C for 30min.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prolidase Activity', 'Obstructive Sleep-Apnea Syndrome'], 'conditions': ['Obstructive Sleep-Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '15888845', 'type': 'BACKGROUND', 'citation': 'Yamauchi M, Nakano H, Maekawa J, Okamoto Y, Ohnishi Y, Suzuki T, Kimura H. Oxidative stress in obstructive sleep apnea. Chest. 2005 May;127(5):1674-9. doi: 10.1378/chest.127.5.1674.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a highly prevalent breathing disorder in sleep. We have aimed to evaluate the relationship between OSA and prolidase activity, the oxidative stress index (OSI), total antioxidative capacity (TAC), and total oxidative capacity (TOC) and the relationship between carotid intima media thickness (CIMT).', 'detailedDescription': 'This study was approved by the local ethics committee in accordance with the Helsinki Declaration. Written informed consent was received from the OSAS Subjects patients and control subjects before enrolment in the study. The patient and control cohorts were recruited from the Pulmonary Medicine Department, Medical Faculty, Yuzuncu Yıl University. Blood samples were analysed at the Biochemistry Laboratory of Harran University Medical Faculty TAC and TOS levels were measured by using an automated measurement method. TAC measurement method involves the production of a potent biological hydroxyl radical. Ferrous ion solution is mixed with hydrogen peroxide. Thus, it is possible to measure the anti-oxidative effect of the sample against the potent free radical reactions initiated by the production of the hydroxyl radical. TOS method is based on the oxidation of ferrous ion to ferric ion in the presence of various oxidant species in acidic medium and the measurement of the ferric ion by xylenol orange. mmol Trolox equivalent (equiv)/L, mmol H2O2 /L and mg/dL, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient (male/female: 43/31) were diagnosed with OSA after night polysomnography (PSG)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients were diagnosed with OSA after night polysomnography (PSG).\n* Patients were enrolled in the study following receipt of their written informed consent.\n\nExclusion Criteria:\n\n* Patients had ischaemic cardiovascular diseases,\n* Patients had chronic obstructive pulmonary diseases,\n* Patients had ischaemic cerebral diseases,\n* Patients had chronic inflammatory diseases,\n* Patients had chronic and acute systemic infections.'}, 'identificationModule': {'nctId': 'NCT03563118', 'briefTitle': 'Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya University'}, 'officialTitle': 'Evaluation of Prolidase as an Oxidative Stress Marker in Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'OSAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group OSAS', 'description': 'We included 56 with OSAS \\[13 subjects 23.2% mild, 19 subjects 33.9% moderate, 24 subjects 42.8% severe'}, {'label': 'control group', 'description': 'simple snoring'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54100', 'city': 'Sakarya', 'state': 'Merkez', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Havva Sayhan, Assis Prof', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}, {'name': 'hulya gunbatar, assosiate. prof.', 'role': 'CONTACT', 'email': 'hulyagunbatar@gmail.com', 'phone': '+905065118827'}], 'facility': 'Sakarya University Research and Training Hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}, {'zip': '54100', 'city': 'Sakarya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Havva Sayhan, Assis Prof', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}, {'name': 'müge yılmaz', 'role': 'CONTACT'}], 'facility': 'Sakarya University Research and Training Hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}], 'centralContacts': [{'name': 'Havva Sayhan', 'role': 'CONTACT', 'email': 'hsayhan@gmail.com', 'phone': '+905056621021'}, {'name': 'hulya gunbatar, asso. prof.', 'role': 'CONTACT', 'email': 'hulyagunbatar@gmail.com', 'phone': '+905065118827'}], 'overallOfficials': [{'name': 'Havva Sayhan', 'role': 'STUDY_CHAIR', 'affiliation': 'Sakarya University Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sakarya University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assiatant prof.', 'investigatorFullName': 'Havva Sayhan', 'investigatorAffiliation': 'Sakarya University'}}}}