Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT05054712
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus
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'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches in the population of patients with T1D.', 'timeFrame': '2 years', 'description': 'To describe the prevalence of metabolic liver diseases (NAFLD and GH) by different diagnostic approaches (levels of transaminases, liver ultrasound, liver MRI and, in selected cases, liver biopsy) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca.'}], 'secondaryOutcomes': [{'measure': 'To study the relationship between metabolic liver diseases in patients with T1D and the degree of metabolic control of diabetes.', 'timeFrame': '2 years'}, {'measure': 'To study the relationship between metabolic liver diseases in patients with T1D and the presence of metabolic syndrome.', 'timeFrame': '2 years'}, {'measure': 'To study the relationship between metabolic liver diseases in patients with T1D and the presence of microvascular and macrovascular complications.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease', 'Glycogen Hepatopathy', 'Type 1 Diabetes', 'Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Nonalcoholic fatty liver disease (NAFLD) has been extensively studied in the context of type 2 diabetes mellitus (T2D) due to its higher prevalence and its association with obesity and syndrome metabolic, a well-established risk factor for NAFLD. Although several studies have reported the accumulation of liver fat in patients with type 1 diabetes mellitus (T1D), the prevalence, etiology, and the consequences of NAFLD in patients with T1D are poorly characterized, requiring more studies in this field. In addition, liver involvement at the metabolic level in patients with T1D raises the differential diagnosis between NAFLD and glycogen hepatopathy (GH), a rare complication associated with the poorly metabolic control of diabetes and probably underdiagnosed, since the ultrasound pattern is the same than the NAFLD. The investigators have designed a cross-sectional observational study with the objective of describing the prevalence of metabolic liver diseases (NAFLD and GH) in the population of patients with T1D in the healthcare area of Hospital del Mar and Hospital de Vilafranca, as well as studying the relationship of these pathologies with the degree of metabolic control, the presence of metabolic syndrome and the presence of micro and macrovascular complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Descriptive observational study of prevalence (cross-sectional) in patients with T1D of the healthcare area of the Hospital del Mar and Hospital de Vilafranca (Barcelona).', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged ≥ 18 years.\n* Diagnosed with T1D of at least 6 months of evolution.\n* Patients who give their informed consent in writing.\n\nExclusion Criteria:\n\n* Active alcoholism\\> 30 g / day in men and\\> 20 g / day in women.\n* Known non-metabolic liver disease: alcoholic hepatitis, viral hepatitis from HBV infection and / or HCV, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, autoimmune hepatitis, hepatic granulomatous (tuberculosis, mycobacteria, histoplasmosis), hepatic lymphoma, primary neoplasia liver, liver metastasis.\n* Active treatment with hepatotoxic drugs: amiodarone, isoniazid, rifampicin, sulfa drugs, tetracyclines, amoxycline / clavulanate, ketoconazole, methotrexate, valproic acid, trazodone, tamoxifen, methyldopa, reverse transcriptase inhibitors, chemotherapy, immunotherapy.\n* Pregnant women.\n* Acute decompensation of T1D (ketoacidosis) in the 3 months prior to inclusion. The inclusion after this period."}, 'identificationModule': {'nctId': 'NCT05054712', 'briefTitle': 'Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Prevalence of Metabolic Liver Diseases in Patients With Type 1 Diabetes Mellitus: Non-alcoholic Fatty Liver Disease and Glycogenic Hepatopathy', 'orgStudyIdInfo': {'id': '21-E5'}}, 'contactsLocationsModule': {'locations': [{'zip': '08720', 'city': 'Vilafranca del Penedès', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Ballesta', 'role': 'CONTACT', 'email': 'sballesta@csap.cat', 'phone': '9381810440', 'phoneExt': '1027'}], 'facility': "Hospital Comarcal de l'Alt Penedès", 'geoPoint': {'lat': 41.34618, 'lon': 1.69713}}, {'zip': '08003', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Ballesta', 'role': 'CONTACT', 'email': 'SBallesta@psmar.cat', 'phone': '+ 34 932 48 30 00', 'phoneExt': '3902'}], 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}