Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-29 @ 10:47 AM
Study NCT ID:
NCT01279928
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2011-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015924', 'term': 'Blood Pressure Monitors'}, {'id': 'D017078', 'term': 'Laser-Doppler Flowmetry'}], 'ancestors': [{'id': 'D019722', 'term': 'Sphygmomanometers'}, {'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012212', 'term': 'Rheology'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-19', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['paediatric and adolescent population', 'nailfold capillaroscopy', 'laser Doppler flowmetry', 'retinal vessel calibre', 'retinal vessel fractal analysis', '24 hour Ambulatory Blood Pressure Monitoring'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24093770', 'type': 'DERIVED', 'citation': 'Hosking SP, Bhatia R, Crock PA, Wright I, Squance ML, Reeves G. Non-invasive detection of microvascular changes in a paediatric and adolescent population with type 1 diabetes: a pilot cross-sectional study. BMC Endocr Disord. 2013 Oct 5;13:41. doi: 10.1186/1472-6823-13-41.'}]}, 'descriptionModule': {'briefSummary': 'This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.\n\nIt was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 8-18 years old\n* Have a diagnosis of type 1 diabetes mellitus\n\nExclusion Criteria:\n\n* \\< 8 years or \\> 18 years old\n* Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)'}, 'identificationModule': {'nctId': 'NCT01279928', 'acronym': 'DIVIDEND', 'briefTitle': 'Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'John Hunter Hospital'}, 'officialTitle': 'Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study', 'orgStudyIdInfo': {'id': 'HNEHREC 09/04/15/5.10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 1 Diabetes Paediatric', 'description': 'Paediatric patients aged 8-18 with diagnosed Diabetes Mellitis Type 1 attending paediatric clinic at John Hunter Hospital.', 'interventionNames': ['Procedure: Video Nailfold Capillaroscopy', 'Device: Ambulatory 24 hr Blood Pressure Monitoring', 'Procedure: Fundoscopy of eyes', 'Procedure: Laser Doppler Flowmetry']}], 'interventions': [{'name': 'Video Nailfold Capillaroscopy', 'type': 'PROCEDURE', 'description': 'Single session of video Nailfold Capillaroscopy wit KKK technology', 'armGroupLabels': ['Type 1 Diabetes Paediatric']}, {'name': 'Ambulatory 24 hr Blood Pressure Monitoring', 'type': 'DEVICE', 'description': '24 hr upper arm cuff measurement of Blood Pressure', 'armGroupLabels': ['Type 1 Diabetes Paediatric']}, {'name': 'Fundoscopy of eyes', 'type': 'PROCEDURE', 'description': 'examination of microvascular health of eye with the use of opthalmoscope', 'armGroupLabels': ['Type 1 Diabetes Paediatric']}, {'name': 'Laser Doppler Flowmetry', 'type': 'PROCEDURE', 'description': 'Examination of vascular flow', 'armGroupLabels': ['Type 1 Diabetes Paediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2305', 'city': 'New Lambton', 'state': 'New South Wales', 'country': 'Australia', 'facility': "John Hunter Children's Hospital", 'geoPoint': {'lat': -32.92838, 'lon': 151.7085}}], 'overallOfficials': [{'name': 'Rani Bhatia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "John Hunter Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'John Hunter Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Associate Professor Glenn Reeves', 'oldOrganization': 'John Hunter Hospital'}}}}