Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT06394206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of a Hospital Intervention in Patients With Hepatic Steatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discharge criteria from the gastroenterology clinic', 'timeFrame': '1 year', 'description': 'Percentage of patients meeting discharge criteria (defined by the trial) from the gastroenterology clinic at the end of the study'}], 'secondaryOutcomes': [{'measure': 'Discharge from the gastroenterology clinic after achieving metabolic control goals', 'timeFrame': '1 year', 'description': 'Difference in the percentage of patients discharged from the gastroenterology clinic after achieving metabolic control goals'}, {'measure': 'Change on Test de Owliver', 'timeFrame': '1 year', 'description': 'Change in the Owliver test compared to baseline'}, {'measure': 'Change on liver enzymes', 'timeFrame': '1 year', 'description': 'Change compared to baseline in the liver enzymes (UI/mL)'}, {'measure': 'Change on total cholesterol', 'timeFrame': '1 year', 'description': 'Change compared to baseline in the total cholesterol (mg/dL)'}, {'measure': 'Change on LDL- cholesterol', 'timeFrame': '1 year', 'description': 'Change compared to baseline in the LDL- cholesterol (mg/dL)'}, {'measure': 'Change on HDL- cholesterol', 'timeFrame': '1 year', 'description': 'Change compared to baseline in the HDL- cholesterol (mg/dL)'}, {'measure': 'Change on triglycerides', 'timeFrame': '1 year', 'description': 'Change compared to baseline in the triglycerides (mg/dL)'}, {'measure': 'Change on Fibrosis-4 Index', 'timeFrame': '1 year', 'description': 'Change compared to baseline on Fibrosis-4 Index'}, {'measure': 'Change on Hepatic Fibrosis', 'timeFrame': '1 year', 'description': 'Change compared to baseline on Fibroscan score'}, {'measure': 'Glycated hemoglobin', 'timeFrame': '1 yera', 'description': 'In diabetic patients, change compared to baseline on glycated hemoglobin'}, {'measure': 'Insulin resistance', 'timeFrame': '1 year', 'description': 'In patients with insulin resistance, change compared to baseline on Insulin Resistance Index'}, {'measure': 'Body Mass Index', 'timeFrame': '1 year', 'description': 'Change compared to baseline on body mass index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fatty Liver', 'Metabolic Syndrome'], 'conditions': ['Hepatic Steatosis']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to determine whether a specialized consultation for controlling metabolic syndrome effectively treats hepatic steatosis in adults. The primary questions it aims to answer are:\n\n• Does this specialized consultation increase the number of patients with hepatic steatosis who show improvement after one year of clinical follow-up in said consultation?\n\nThe improvement of the disease will be assessed through the following parameters:\n\n* liver laboratory tests\n* weight loss\n* improvement in cholesterol and triglyceride levels. Researchers will compare follow-up in the specialized consultation to standard follow-up to assess the effectiveness of the specialized consultation in treating hepatic steatosis.\n\nParticipants will be randomly assigned to two groups. The first group will be visited in the specialized consultation every three months for one year and will continue to receive the rest of their follow-up visits. The second group will undergo their usual follow-up visits but will not be visited in the specialized consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen in outpatient gastroenterology clinics with hepatic steatosis.\n* Diagnosed with hepatic steatosis through ultrasound or abdominal CT scan\n* Mild to moderate fibrosis as assessed by elastography or FibroScan (F1-F3) or with a Fibrosis-4 (FIB-4) Index less than 3.5.\n* Signature of informed consent for study inclusion, either by the participant themselves or by their legal representative.\n\nExclusion Criteria:\n\n* Patients who do not have any hepatic imaging test conducted in the last 5 years.\n* Conditions other than hepatic steatosis requiring gastroenterological follow-up.\n* Abusive alcohol consumption, defined as weekly intake of \\> 50 g in women and more than 70 g in men.\n* Cognitive or affective disorders limiting the ability to cooperate with study procedures.\n* Participation in another clinical trial involving experimental intervention during the period of this trial and/or establishing visit schedules incompatible with this trial.'}, 'identificationModule': {'nctId': 'NCT06394206', 'acronym': 'BIPEH', 'briefTitle': 'Benefit of a Hospital Intervention in Patients With Hepatic Steatosis', 'organization': {'class': 'OTHER', 'fullName': "Consorci Sanitari de l'Alt Penedès i Garraf"}, 'officialTitle': 'Benefit of a Hospital Intervention in Patients With Hepatic Steatosis', 'orgStudyIdInfo': {'id': 'CSAPG-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Specialized Unit', 'description': 'This group of participants will be visited in the specialized consultation and will continue to receive the rest of their follow-up visits.', 'interventionNames': ['Other: Specialized Unit', 'Other: Usual Follow-Up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Follow-Up', 'description': 'This group of participants will undergo their usual follow-up visits but will not be visited in the specialized consultation.', 'interventionNames': ['Other: Usual Follow-Up']}], 'interventions': [{'name': 'Specialized Unit', 'type': 'OTHER', 'description': 'The participant will be visited every three months for one year', 'armGroupLabels': ['Specialized Unit']}, {'name': 'Usual Follow-Up', 'type': 'OTHER', 'description': 'The participant will be visited as usual, it means they will be visited at Digestive Consultation', 'armGroupLabels': ['Specialized Unit', 'Usual Follow-Up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08810', 'city': 'Sant Pere de Ribes', 'state': 'Barcelona', 'country': 'Spain', 'contacts': [{'name': 'Lidia Tikhomirova', 'role': 'CONTACT', 'email': 'ltikhomirova@csapg.cat', 'phone': '+34 938960025'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 938960025', 'phoneExt': '43197'}, {'name': 'Lidia Tikhomirova, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Consorci Sanitari Alt Penedes i Garraf', 'geoPoint': {'lat': 41.26045, 'lon': 1.77391}}], 'centralContacts': [{'name': 'Lidia Tikhomirova, MD', 'role': 'CONTACT', 'email': 'ltikhomirova@csapg.cat', 'phone': '+34 938960025'}, {'name': 'Noemí Casaponsa', 'role': 'CONTACT', 'email': 'recerca@csapg.cat', 'phone': '+34 938960025', 'phoneExt': '43197'}], 'overallOfficials': [{'name': 'Lidia Tikhomirova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSAPG'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After publication of main results of the study.', 'ipdSharing': 'YES', 'description': 'IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).', 'accessCriteria': 'IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Consorci Sanitari de l'Alt Penedès i Garraf", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}