Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-01 @ 11:46 PM
Study NCT ID:
NCT06816303
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2025-02-06', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'glycosilated hemoglobin (%)', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'glycometabolic control in relation to therapy'}], 'secondaryOutcomes': [{'measure': 'degree of satisfaction with therapy', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'degree of satisfaction with therapy through the administration of Diabetes Treatment Satisfaction Questionnaire (DTSQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus Type 2', 'Liver Transplant']}, 'descriptionModule': {'briefSummary': 'observational study through which we aim to collect information on metabolic compensation, the degree of satisfaction with hypoglycemic therapy, the onset of complications of diabetes or liver disease, evaluation of survival, in patients on the list for at least three months or already undergoing liver transplantation for at least three months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients followed for hepatological problems on the list for OLT or post-transplant with type 2 diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus\n* presence on the list for OLT for at least 3 months or have already been submitted to OLT for at least 3 months\n* age ≥ 18 years\n* signature of written informed consent to participate in the observational study, either by the participant or legal guardian\n\nExclusion Criteria:\n\n\\- Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06816303', 'acronym': 'DiaBoLT2021', 'briefTitle': 'Patients With Diabetes Mellitus on Drug Treatment on the List or Already Undergoing Orthotopic Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Adult Patients With Diabetes Mellitus, on Drug Treatment, on the List or Already Undergoing Orthotopic Liver Transplantation: an Observational Study', 'orgStudyIdInfo': {'id': 'DiaBoLT2021'}}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucia Brodosi', 'role': 'CONTACT', 'email': 'lucia.brodosi2@unibo.it', 'phone': '+390512143248'}], 'facility': 'Lucia Brodosi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Lucia Brodosi', 'role': 'CONTACT', 'email': 'lucia.brodosi2@unibo.it', 'phone': '+39 0512143248'}], 'overallOfficials': [{'name': 'Lucia Brodosi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}