Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-06 @ 11:54 AM
Study NCT ID:
NCT06445361
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of NAFLD in T1DM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of NAFLD in T1DM', 'timeFrame': 'During the intervention', 'description': 'To determine the prevalence of steatosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with controlled attenuation parameter (CAP) measurements.'}, {'measure': 'Prevalence of fibrosis in T1DM', 'timeFrame': 'During the intervention', 'description': 'To determine the prevalence of fibrosis in a cohort of T1DM patients followed at the Departments of Endocrinology in ZOL by means of the FibroScan® device with vibration controlled attenuation parameter (VCTE) measurements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD', 'Type 1 Diabetes', 'Fatty Liver, Nonalcoholic']}, 'descriptionModule': {'briefSummary': 'To determine the prevalence of NAFLD in T1DM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* T1DM\n* ≥ 18 years of age\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Excessive alcohol use\n* Exclusion of other causes of liver disease and secondary causes of liver steatosis'}, 'identificationModule': {'nctId': 'NCT06445361', 'acronym': 'PAD1ZOL', 'briefTitle': 'Prevalence of NAFLD in T1DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium', 'orgStudyIdInfo': {'id': 'Z-2022007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study cohort', 'description': 'FibroScan measurement', 'interventionNames': ['Diagnostic Test: FibroScan']}], 'interventions': [{'name': 'FibroScan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performance of a FibroScan measurement to determine steatosis and fibrosis.', 'armGroupLabels': ['Study cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Leen Heyens, MsC', 'role': 'CONTACT', 'email': 'NAFLDstudie@zol.be', 'phone': '089 21 20 55', 'phoneExt': '+32'}], 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'centralContacts': [{'name': 'Leen Heyens, MsC', 'role': 'CONTACT', 'email': 'nafldstudie@zol.be', 'phone': '089 21 20 55', 'phoneExt': '+32'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'During the study period IPD will not be made available for other researchers. When the study is completed and results are reported, IPD can be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}