Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-27 @ 10:22 PM
Study NCT ID:
NCT00947635
Status:
COMPLETED
Last Update Posted:
2009-07-28
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-24', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol and fatty acid synthesis', 'timeFrame': 'Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)'}], 'secondaryOutcomes': [{'measure': 'Blood lipid levels', 'timeFrame': 'Pre-transplant, post-transplant (>3 months after transplant, up to 2 years) and post-dietary intervention (1 month after post-transplant measurement)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 1 diabetes', 'Transplants', 'Immunosuppression', 'Hyperlipidemia', 'Nutrition Therapy'], 'conditions': ['Immunosuppression', 'Hyperlipidemias', 'Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The purpose is to investigate possible mechanisms of increased blood lipid levels following transplantation, and also to see if a comprehensive dietary intervention is effective in reducing blood lipid levels in post-transplant patients.', 'detailedDescription': 'Post-transplantation patients frequently have an increase in blood lipid levels presumed to be due to immunosuppressive agents, however it is currently unknown the mechanisms by which this occurs. Dietary interventions have frequently been unsuccessful in these patients, which may be due to single-nutrient interventions and lack of support and guidance. This research will use stable isotope methods to estimate cholesterol and fatty acid synthesis to determine if these pathways are affected by immunosuppression in patients before and after islet and liver transplant. In addition, it will be determined if a multi-nutrient dietary intervention will be implemented post-transplant can reduce blood lipid levels in to prevent further polypharmacy these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* on islet or liver transplant list\n* post-transplant \\>3 months\n* physically able to participate in study and intervention\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* family history of premature cardiovascular disease or familial hyperlipidemia (control subjects)\n* cholestatic diseases (liver transplant patients)\n* type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT00947635', 'briefTitle': 'Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Cholesterol and Fatty Acid Synthesis in Islet and Liver Transplant Patients and Effect of Dietary Intervention', 'orgStudyIdInfo': {'id': 'Islet-Liver-MTC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Islet transplant', 'description': 'People with Type 1 diabetes undergoing islet transplantation', 'interventionNames': ['Dietary Supplement: Dietary intervention - supplements']}, {'type': 'EXPERIMENTAL', 'label': 'Liver transplant', 'description': 'People with liver failure undergoing liver transplantation', 'interventionNames': ['Dietary Supplement: Dietary intervention - supplements']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Healthy normal people which serve as control group', 'interventionNames': ['Dietary Supplement: Dietary intervention - supplements']}], 'interventions': [{'name': 'Dietary intervention - supplements', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplement bar \\& spread formulated with key nutrients (fish oil, phytosterols, almonds, soy protein) shown to help in reducing blood lipid levels', 'armGroupLabels': ['Control', 'Islet transplant', 'Liver transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2P5', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Michael T Clandinin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr. Michael T. Clandinin', 'oldOrganization': 'University of Alberta'}}}}