Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-04-13 @ 4:58 AM
Study NCT ID:
NCT05958420
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2023-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HDL Subfractions', 'timeFrame': 'Blood will collected from all patients before surgery', 'description': 'Evaluation of HDL Subfractions in groups'}], 'secondaryOutcomes': [{'measure': 'HDL-associated enzymes', 'timeFrame': 'Blood will collected from all patients before surgery', 'description': 'ApoA1, CETP and LCAT levels in groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver Failure', 'HDL Subfractions', 'ApoA1', 'CETP', 'LCAT'], 'conditions': ['Liver Failure']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.', 'detailedDescription': 'Objectives: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.\n\nMaterials and Methods: Twenty liver failure patients and twenty healthy donors are selected. Blood samples obtained from all patients prior to transplant will analyzed. HDL subfraction analysis will done by continuous disc polyacrylamide gel electrophoresis. Plasma levels of apolipoprotein A-1 (ApoA-I), cholesteryl ester transfer protein (CETP), and lecithin-cholesterol acyltransferase (LCAT) will determined by enzyme-linked immunosorbent assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients who underwent living donor LT procedure between 2018 and 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver failure patients\n\nExclusion Criteria:\n\n* patients not giving consent\n* Participants who had oncological and hematological diseases, coronary failure, kidney failure, malnutrition, diabetes, traumatic brain injury, or cadaveric LT and who were using psychoactive medicines or having a respiratory system or CNS diseases were excluded from the study'}, 'identificationModule': {'nctId': 'NCT05958420', 'briefTitle': 'Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors', 'orgStudyIdInfo': {'id': 'KC-HDL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients with liver failure'}, {'label': 'Group 2', 'description': 'Healthy donors'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'AkdenizU', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'İlker O Aycan', 'role': 'STUDY_CHAIR', 'affiliation': 'Akdeniz University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. İlker Öngüç Aycan', 'investigatorFullName': 'İlker Onguc Aycan', 'investigatorAffiliation': 'Akdeniz University'}}}}