Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-02 @ 7:55 AM
Study NCT ID:
NCT06445335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of NAFLD in T2DM Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 385}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients', 'timeFrame': 'Baseline', 'description': 'To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients followed at the department of Endocrinology in Ziekenhuis Oost-Limburg (ZOL), Genk, Belgium by means of FibroScan measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD', 'T2D', 'Type 2 Diabetes', 'Fatty Liver, Nonalcoholic']}, 'descriptionModule': {'briefSummary': 'To determine the prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Having type 2 diabetes mellitus (T2DM)\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 steatosis'}, 'identificationModule': {'nctId': 'NCT06445335', 'acronym': 'PAD2ZOL', 'briefTitle': 'Prevalence of NAFLD in T2DM Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ziekenhuis Oost-Limburg'}, 'officialTitle': 'The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium', 'orgStudyIdInfo': {'id': 'CTU2019009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FibroScan', 'interventionNames': ['Diagnostic Test: FibroScan']}], 'interventions': [{'name': 'FibroScan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performance of a FibroScan measurement.', 'armGroupLabels': ['FibroScan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Genk', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Mathieu Struyve, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziekenhuis Oost-Limburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}