Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05695118
Status:
UNKNOWN
Last Update Posted:
2023-08-18
First Post:
2022-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Body Composition and Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2022-12-24', 'studyFirstSubmitQcDate': '2023-01-14', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'incidence of incidental finding', 'timeFrame': '6 month after CT acquisition', 'description': 'incidentally detected findings on low-dose abdomen CT'}], 'primaryOutcomes': [{'measure': 'relationship between body composition analysis result from CT and liver fat fraction', 'timeFrame': '6 month after CT acquisition', 'description': 'relationship between visceral fat volume fraction (obtained from CT analysis using automatic body segmentation, unitless (visceral fat fraction = visceral fat volume/total body volume)) and CAP value of fibroscan'}], 'secondaryOutcomes': [{'measure': 'ratio of appropriate non-contrast low dose abdomen CT acquisition & analysis', 'timeFrame': '6 month after CT acquisition', 'description': 'Number of CT scan with effective dose \\< 1.5 mSv AND successful automatic body composition analysis (without manual editing) divided by total number of CT scan'}, {'measure': 'relationship between body composition analysis result from CT and hepatic fibrosis', 'timeFrame': '6 month after CT acquisition', 'description': 'relationship between visceral fat volume fraction (CT analysis using automatic body segmentation, unitless (visceral fat fraction = visceral fat volume/total body volume)) and liver stiffness value of fibroscan'}, {'measure': 'agreement between body composition analysis result from CT and bioelectrical impedance analysis (Inbody test)', 'timeFrame': '6 month after CT acquisition', 'description': 'agreement of visceral fat, subcutaneous fat, muscle amount between CT based body composition and Inbody test results'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT'], 'conditions': ['Fatty Liver']}, 'descriptionModule': {'briefSummary': 'This study investigates relationship between fatty liver prognosis and body composition analysis result based on non-contrast low dose CT in patients with fatty liver disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* metabolic dysfunction-associated fatty liver disease (fatty liver with overweight/obesity, or type II DM or other metabolic dysfunction)\n* or non-alcoholic fatty liver disease with liver function test abnormality\n* signed informed consent\n\nExclusion Criteria:\n\n* chronic hepatitis B or C\n* other disease related to fatty liver such as glycogen storage disease, lipodystrophy, familial combined hyperlipidemia, hypobetalipoproteinemia, Weber-Christian syndrome or abetalipoproteinemia\n* on medication related to hepatic steatosis (tamoxifen, steroid, valproic acid, methotrexate, amiodarone)\n* diabetes after pancreatectomy\n* history of total parenteral nutrition in 6 months\n* pregnancy or nursing mother'}, 'identificationModule': {'nctId': 'NCT05695118', 'briefTitle': 'Body Composition and Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Analysis of the Prognostic Correlation Between Body Composition Analysis and Fatty Liver Progression in Patients With Fatty Liver Using Low-dose CT', 'orgStudyIdInfo': {'id': 'SNUH-2022-3238'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non-contrast low-dose abdomen CT', 'description': 'non-contrast low-dose abdomen CT (target effective dose: \\< 1.5 mSv). CT based body composition analysis is performedd with commercially available automatic segmentation software (DeepCatch, Medical IP, South Korea).', 'interventionNames': ['Diagnostic Test: Non-contrast low-dose abdomen CT', 'Diagnostic Test: Fibroscan', 'Diagnostic Test: bioelectrical impedance analysis (BIA)']}], 'interventions': [{'name': 'Non-contrast low-dose abdomen CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'target effective dose: \\< 1.5 mSv It is performed twice in 6-month interval.', 'armGroupLabels': ['non-contrast low-dose abdomen CT']}, {'name': 'Fibroscan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fibroscan is performed within a week of low-dose CT. It is used as a reference standard of hepatic fibrosis and steatosis.', 'armGroupLabels': ['non-contrast low-dose abdomen CT']}, {'name': 'bioelectrical impedance analysis (BIA)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Inbody test (commercial name)'], 'description': 'BIA test is performed on the same day of low-dose CT. Commercially available model (Inbody 270) is used.', 'armGroupLabels': ['non-contrast low-dose abdomen CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jeong Min Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jeong Min Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}