Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-29 @ 7:40 AM
Study NCT ID:
NCT04232293
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2020-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'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': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 722}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eLift and FibroMeter sensitivity for the diagnosis of advanced hepatic fibrosis', 'timeFrame': 'Day 0', 'description': 'sensitivity calculated as follows: (number of patients with advanced hepatic fibrosis and a positive test) / (number of patients with advanced hepatic fibrosis)'}], 'secondaryOutcomes': [{'measure': 'number of advanced hepatic fibrosis diagnosed according to the FibroScan composite criterion and then liver biopsy', 'timeFrame': '3 months'}, {'measure': 'Controlled Attenuation Parameter (CAP) measurement by FibroScan', 'timeFrame': '3 months'}, {'measure': 'Patient rate with eLIFT ≥8 versus FibroMeter ≥0.22.', 'timeFrame': 'Day 0'}, {'measure': 'Liver hardness (kPa) measured by FibroScan', 'timeFrame': '3 months'}, {'measure': 'Complication of diabetes', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NASH', 'NAFLD', 'Fibrosis', 'Cirrhosis', 'Type 2 Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus, Type 2', 'NAFLD', 'NASH']}, 'descriptionModule': {'briefSummary': "Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.\n\nTo be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 40 years old,\n* Type 2 diabetes mellitus for more than 6 months,\n* BMI \\> 25 kg/m2,\n* Waist circumference \\> 94 cm (male) or 80 cm (female).\n* Patient benefiting from a social security system.\n\nExclusion Criteria:\n\n* Medical follow up for liver disease,\n* Decompensated cirrhosis,\n* Health status that does not allow the participation of the patient,\n* Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,…\n* HbA1c \\> 11,0 %,\n* Pregnancy.\n* Patient under guardianship or curatorship or protection of justice\n* Involvement refusal."}, 'identificationModule': {'nctId': 'NCT04232293', 'acronym': 'L-FibroT2DM', 'briefTitle': 'Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'RC19_0425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood tests', 'description': 'Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis', 'interventionNames': ['Diagnostic Test: Blood tests']}], 'interventions': [{'name': 'Blood tests', 'type': 'DIAGNOSTIC_TEST', 'description': 'eLift and FibroMeter', 'armGroupLabels': ['Blood tests']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': "CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Bertrand CARIOU, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes Hospital University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}