Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-29 @ 12:10 AM
Study NCT ID:
NCT01184768
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2010-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HBA1c and Diagnosis 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'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3509}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with new diagnosis of type 2 diabetes', 'timeFrame': 'Up to 2 years after participation in the 6th Tromso study'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with new diagnosis of impaired glucose tolerance', 'timeFrame': 'Up to 2 years after participation in the 6th Tromso study'}, {'measure': 'Number of subjects with new diagnosis of impaired fasting glucose', 'timeFrame': 'Up to 2 years after participation in the 6th Tromso study'}, {'measure': 'Effect of vitamin D status on glucose tolerance', 'timeFrame': 'Up to 2 years after participation in the 6th Tromso study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 2 diabetes', 'HbA1c', 'vitamin D', 'diagnosis'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'Following the 6th Tromso study subjects with HbA1c \\> 5.7 plus a subsample of subjects with lower hba1c values will be invited to an oral glucose tolerance test to see the predictive value of HBA1c in the diagnosis of type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'random sample of subjects living in Tromso and who participated in the 6 th Tromsø study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participated in the 6 Tromso study\n\nExclusion Criteria:\n\n* type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT01184768', 'briefTitle': 'HBA1c and Diagnosis of Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Tromso'}, 'officialTitle': 'HBA1c and Diagnosis of Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'UIT-ENDO-2010-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'participants in the 6th tromsø study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9038', 'city': 'Tromsø', 'state': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'rolf jorde, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tromso'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tromso', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Rolf Jorde', 'oldOrganization': 'University of Tromsø'}}}}