Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00609102
Status:
COMPLETED
Last Update Posted:
2014-12-24
First Post:
2008-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antioxidant Treatment of Type 2 Diabetes
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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-22', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'HbA1c levels', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Type 2 diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -\n\nExclusion Criteria: None, except known intolerance to n-acetylcysteine\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00609102', 'briefTitle': 'Antioxidant Treatment of Type 2 Diabetes', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'orgStudyIdInfo': {'id': 'Antioxidant trmt type 2'}, 'secondaryIdInfos': [{'id': 'NIH R01 38325-19'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antioxidant drug', 'description': 'n-acetylcysteine', 'interventionNames': ['Drug: n-aceylcysteine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'one capsule BID', 'armGroupLabels': ['Placebo']}, {'name': 'n-aceylcysteine', 'type': 'DRUG', 'description': '450 mgm BID', 'armGroupLabels': ['antioxidant drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Pacific Northwest Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'R. Paul Robertson', 'oldOrganization': 'Pacific Northwest Research Institute'}}}}