Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT07098520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2024-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers of Steatohepatitis in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma and serum aliquots'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2024-04-27', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FIB-4 (Fibrosis-4) index', 'timeFrame': 'Cross sectional study - one day of clinical investigation', 'description': "FIB-4 index - marker of liver fibrosis (calculated from variables provided below) will be evaluated in all subjects.\n\nFIB-4 index is calculated as follows: FIB-4 = (Age × AST) / (Platelets × √ALT). This requires values: the patient's age in years, AST (aspartate aminotransferase) in U/L, ALT (alanine aminotransferase) in U/L, and platelet count in 10\\^9/L.\n\nA score below 1.3 suggests minimal fibrosis, while a score above 3.25 indicates advanced fibrosis."}], 'secondaryOutcomes': [{'measure': 'ELF (Enhanced Liver Fibrosis) score', 'timeFrame': 'Cross sectional study - one day of clinical investigation', 'description': 'ELF (Enhanced Liver Fibrosis) score will be determined in all subjects.\n\nThe ELF score is calculated as follows: ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1), where HA represents serum concentration of hyaluronic acid in ng/mL, PIINP represents serum concentration of procollagen III N-terminal peptide in ng/mL and TIMP-1 represents serum concentration of tissue inhibitor of metalloproteinase in ng/mL.\n\nThe reference range of the ELF score (7.14-9.55), higher values suggest more advanced liver fibrosis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Steatosis of Liver']}, 'descriptionModule': {'briefSummary': 'The aims of the study are to identify a subgroup of type 2 diabetics at risk of developing and progressing to non-alcoholic steatohepatitis (NASH), to correlate clinical and laboratory parameters with sonographic and elastographic findings in order to pinpoint indicators of liver fibrosis (NASH), and to facilitate targeted screening and intensified management of type 2 diabetes mellitus to prevent NASH complications.', 'detailedDescription': 'Hepatic steatosis, known as non-alcoholic fatty liver disease (NAFLD), is prevalent among type 2 diabetes mellitus patients. NAFLD encompasses benign hepatic steatosis and non-alcoholic steatohepatitis (NASH), the latter being a hepatic complication linked to metabolic syndrome. Insulin resistance and dysregulation of fatty acid metabolism contribute to its pathogenesis, leading to oxidative stress, hepatocyte damage, and fibroproduction, eventually progressing to cirrhosis and hepatocellular carcinoma.\n\nIdentification of high-risk NAFLD patients, particularly those with NASH, is crucial for early intervention and monitoring. However, distinguishing between benign steatosis and NASH poses a clinical challenge. Liver biopsy remains the gold standard for NASH diagnosis but is invasive and impractical for routine screening in diabetic patients.\n\nThe study aims to identify high-risk type 2 diabetics prone to NASH progression by correlating clinical and laboratory parameters with sonographic and elastographic findings. Parameters such as diabetes duration, BMI, waist/hip ratio, glycated hemoglobin, and liver function tests will be compared with real-time shear wave elastography results. This approach seeks to pinpoint indicators of liver fibrosis (NASH), facilitating targeted screening and intensified management of type 2 diabetes mellitus, potentially averting NASH complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with Type 2 diabetes mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType 2 diabetes diagnosis\n\nExclusion Criteria:\n\nAlcohol abuse (anamnestic) Hepatitis Other known liver disease (other than steatosis/steatohepatitis)'}, 'identificationModule': {'nctId': 'NCT07098520', 'acronym': 'STEDIB', 'briefTitle': 'Biomarkers of Steatohepatitis in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty Hospital Kralovske Vinohrady'}, 'officialTitle': 'Biomarkers of Steatohepatitis in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': 'STEDIB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes type 2', 'description': 'Patients diagnosed with type 2 diabetes', 'interventionNames': ['Other: No intervention, just observation']}], 'interventions': [{'name': 'No intervention, just observation', 'type': 'OTHER', 'description': 'no intervention, study investigates biomarkers associated with a disease', 'armGroupLabels': ['Diabetes type 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Jan Polak, MD, PhD', 'role': 'CONTACT', 'email': 'jan.polak@lf3.cuni.cz', 'phone': '+420731181599'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'The data will be made available starting 6 months after the study completion date for 10 years.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study will be provided to qualified researchers with a legitimate research interest.', 'accessCriteria': 'Access to the data will be granted following the review and approval of a research proposal and a signed Data Sharing Agreement (DSA). Requests for access can be submitted via email to jan.polak@lf3.cuni.cz'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician, principal investigator', 'investigatorFullName': 'Jan Polak', 'investigatorAffiliation': 'Faculty Hospital Kralovske Vinohrady'}}}}