Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT05808192
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007166', 'term': 'Immunosuppressive Agents'}], 'ancestors': [{'id': 'D007155', 'term': 'Immunologic Factors'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'relation between MS development and IS in LT recipients', 'timeFrame': '5 years', 'description': 'Evaluate the de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those who could not withdraw IS ("non-tolerant").'}], 'secondaryOutcomes': [{'measure': 'IS withdrawal in LT recipients', 'timeFrame': '5 years', 'description': 'Evaluate the clinical course of patients undergoing discontinuation of immunosuppressive therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic Syndrome, Liver transplantation, Immunosoppression, Tolerance'], 'conditions': ['Single Transplant', '5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS']}, 'descriptionModule': {'briefSummary': 'Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").', 'detailedDescription': "A retrospective single-center study was conducted aiming to define the incidence of de novo Metabolic Syndrome (MS) in patients who withdraw Immunosoppression (IS) drugs after Liver Transplant (Tolerant-group) compared to these who couldn't wean IS drugs(non-TOL-group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '49 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '92 patients with liver transplantation who attempted to suspend/ achieve suspension of immunosuppressive therapy, in follow-up in Tor Vergata transplant center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* single LT recipients with an attempt of IS withdrawal\n* minimum 5 years follow-up\n\nExclusion Criteria:\n\n* Liver transplant combined with other organs\n* Presence of metabolic syndrome and/or NASH and/or NAFLD as an indication for liver transplantation\n* Loss of patient to follow-up'}, 'identificationModule': {'nctId': 'NCT05808192', 'briefTitle': 'De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal', 'orgStudyIdInfo': {'id': 'R.S.123.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'tolerant', 'description': 'patients who withdraw IS drugs after LT', 'interventionNames': ['Drug: Immunosuppressive']}, {'label': 'non tolerant', 'description': "patients who couldn't wean IS drugs", 'interventionNames': ['Drug: Immunosuppressive']}], 'interventions': [{'name': 'Immunosuppressive', 'type': 'DRUG', 'description': 'compare MS development in patients who achieve to suspend IS drugs after LT and in those who could not suspend.', 'armGroupLabels': ['non tolerant', 'tolerant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Roberta Angelico', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Roberta Angelico', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}