Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 3:55 PM
Study NCT ID:
NCT01129232
Status:
TERMINATED
Last Update Posted:
2018-05-17
First Post:
2010-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diabetes Virus Detection Project, Intervention With GAD-alum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Complications to procedure', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies', 'timeFrame': '18 months after inclusion'}, {'measure': 'Prevalence of virus infected islets in pancreatic biopsies', 'timeFrame': '18 months after inclusion'}, {'measure': 'Intensity of insulitis in proportion to living, insulin-staining beta cells in pancreatic biopsies', 'timeFrame': '2 weeks after inclusion'}, {'measure': 'Prevalence of virus infected islets in pancreatic biopsies', 'timeFrame': '2 weeks after inclusion'}], 'secondaryOutcomes': [{'measure': 'Residual insulin secretion (C-peptide) measured by Mixed Meal Tolerance Test', 'timeFrame': '36 months after diagnosis', 'description': 'Will be measured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months'}, {'measure': 'Insulin dosage/kilo bodyweight/24 hours', 'timeFrame': '36 months after diagnosis', 'description': 'Will be calculated at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is 36 months after diagnosis'}, {'measure': 'Glycosylated hemoglobin A1 (HbA1c)', 'timeFrame': '36 months after diagnosis', 'description': 'Will be measrured at 0, 1, 3, 9, 18, 24 and 36 months after diagnosis, but time frame is at 36 months. To investigate wether an eventual better endogenous insulin production gives better metabolic control, estimated by lower HbAic'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['insulin'], 'conditions': ['Diabetes, Type I', 'Enterovirus Infections', 'Autoimmunity']}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to test whether GAD vaccination can stop the progression of newly diagnosed type 1 diabetes, to describe the related immunological processes (insulitis) in pancreas and small intestines evolving the mechanism of the effect of GAD vaccination and finally try to detect viruses and virus receptors directly in the insulin producing beta cells of the pancreas in patients with newly diagnosed type-1 diabetes mellitus (T1D).', 'detailedDescription': 'The aetiology of type 1 diabetes is unknown. Both genetic and environmental factors seem to be important for the destruction of insulin producing beta cells in the pancreas. Increasing indirect evidences exist that picornaviruses may either directly or indirectly through autoimmune processes destroy beta cells. New sensitive assays have been developed to detect these viruses and to study the immunological processes, especially T-cell function. Microsurgical technology has been refined, now making pancreatic biopsies a safe procedure. This study focuses on advanced in depth studies of immunology and virology in pancreatic tissue and small intestine at an early stage of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed classical type-1 diabetes\n* Positive GAD antibodies\n* Fasting C-peptide \\>0.1 mmol/l\n* Insulin dosage \\>0.1 U/kg Bodyweight/day\n\nExclusion Criteria:\n\n* Pregnancy\n* Weaning\n* Other chronic diseases than diabetes\n* Any regular medication except oral contraceptives\n* Psychiatric disturbances'}, 'identificationModule': {'nctId': 'NCT01129232', 'acronym': 'DiViD', 'briefTitle': 'Diabetes Virus Detection Project, Intervention With GAD-alum', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'A Phase II-study (Therapeutic Exploratory) of GAD-alum in Newly Diagnosed Type-1 Diabetic Patients, With Focus One the Presence of Viruses at the Time of Diagnosis', 'orgStudyIdInfo': {'id': '2009/1907 (REK)'}, 'secondaryIdInfos': [{'id': '2008-002027-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GAD-alum', 'description': 'GAD-alum administered at 0 and 1 months after inclusion', 'interventionNames': ['Drug: GAD-alum']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GAD-alum', 'type': 'DRUG', 'otherNames': ['Diamyd'], 'description': '20 µg of GAD-alum injected sc after the biopsy, and repeated after one month', 'armGroupLabels': ['GAD-alum']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0514', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Endokrinologisk poliklinikk, Oslo Universitetssykehus Aker', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Knut Dahl-Jorgensen, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assosciate professor', 'investigatorFullName': 'Lars Krogvold', 'investigatorAffiliation': 'Oslo University Hospital'}}}}