Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-03-20 @ 4:59 AM
Study NCT ID:
NCT00618761
Status:
UNKNOWN
Last Update Posted:
2012-06-15
First Post:
2008-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-14', 'studyFirstSubmitDate': '2008-02-06', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2012-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin secretion during clamp test', 'timeFrame': 'time 0'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glucose clamp', 'beta-cell'], 'conditions': ['Kidney Transplantation', 'Pancreas Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare functional beta-cell mass using the hyperglycaemic clamp test in insulin-independent pancreas-kidney recipients with that in non-diabetic kidney recipients and normal controls as well as with the partially previously reported data in beta-cell recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* kidney pancreas recipients\n* kidney recipients\n* healthy volunteers\n* beta-cell recipients\n* immunosuppression with MMF-Tacrolimus\n* 1-4 years after transplantation\n\nExclusion Criteria:\n\n* high doses of steroids\n* insulin dependent'}, 'identificationModule': {'nctId': 'NCT00618761', 'briefTitle': 'Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Controls', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gasthuisberg'}, 'officialTitle': 'Insulin Secretory Capacity in Insulin-independent Pancreas-Kidney Recipients Compared to Non-Diabetic Kidney Recipients, Insulin Independent Recipients of Beta-cell Grafts and Healthy Controls.', 'orgStudyIdInfo': {'id': 'clamp01'}, 'secondaryIdInfos': [{'id': 'JDRF 4/2005/1327'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'kidney-pancreas recipients', 'interventionNames': ['Other: hyperglycemic clamp test']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'kidney recipients', 'interventionNames': ['Other: hyperglycemic clamp test']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'healthy controls', 'interventionNames': ['Other: hyperglycemic clamp test']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'beta-cell recipients', 'interventionNames': ['Other: hyperglycemic clamp test']}], 'interventions': [{'name': 'hyperglycemic clamp test', 'type': 'OTHER', 'description': 'hyperglycemic clamp test', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pieter Gillard, M.D.', 'role': 'CONTACT', 'email': 'pieter.gillard@uz.kuleuven.ac.be', 'phone': '003216346994'}, {'name': 'Pieter Gillard, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Endocrinology, Leuven, UZ-Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Chantal Mathieu, M.D., PhD.', 'role': 'CONTACT', 'email': 'chantal.mathieu@uz.kuleuven.ac.be', 'phone': '0032/16/346994'}], 'overallOfficials': [{'name': 'Chantal Mathieu, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ-Gasthuisberg, Department of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gasthuisberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}, {'name': 'Fund for Scientific Research, Flanders, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Dr', 'investigatorFullName': 'Pieter Gillard', 'investigatorAffiliation': 'University Hospital, Gasthuisberg'}}}}