Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01136902
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2010-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005951', 'term': 'Glucose Tolerance Test'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Venous blood sample. Na+, K+, Crea, HbA1c. Capillary glucose measurement. Samples will be analysed and destructed according to normal laboratory practice at the Glostrup Hospital.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2010-06-01', 'studyFirstSubmitQcDate': '2010-06-03', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vessel caliber', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Blood glucose level', 'timeFrame': '1 day', 'description': 'Capillary samples.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Retinal Vessels', 'Physiology'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The overall objective is to investigate, whether retinal blood vessel diameter change during the energy consuming dark adaptation process and if responses vary between low and high blood glucose.', 'detailedDescription': 'All subjects are being studied using the same procedure. The study schedule takes place from 8 a.m. to 12 a.m. every time. Each subject shows up on one single day. Subjects are to show up fasting overnight with a break in insulin and/or oral antidiabetic treatment.\n\nThe study eye of each subject will be selected by randomisation. We seek to have an equal distribution of right and left eyes overall.\n\nA first set of images will be taken after 5 minutes in "standardised daylight", in a room without light from outside, which eliminates any concerns about weather variations. After this the room is completely darkened. 2 set of images will be taken in the dark adapted state after 20 and 40 minutes. Subsequently the patient ingests the OGTT and will reach maximum blood glucose level after about 60-90 minutes. At this time, the subjects undergo the same "photo session" as above with high blood glucose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with diagnosed Type 2 diabetes mellitus with none or minimal diabetic retinopathy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic individuals.\n* minimal or no diabetic retinopathy defined by no more than five microaneurysms or dot hemorrhages per eye on three non-stereoscopic 50 degree color fundus photographs\n\nExclusion Criteria:\n\n* Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease'}, 'identificationModule': {'nctId': 'NCT01136902', 'briefTitle': 'Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Measuring Retinal Vessel Caliber in Relation to Dark Adaptation and Blood Glucose Level', 'orgStudyIdInfo': {'id': 'Kappelgaard, vessel'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 DM', 'description': 'This group includes subjects diagnosed with type 2 diabetes mellitus with none or minimal diabetic retinopathy.', 'interventionNames': ['Dietary Supplement: Oral Glucose Tolerance Test (OGTT)']}], 'interventions': [{'name': 'Oral Glucose Tolerance Test (OGTT)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['OGTT'], 'description': '75 g of glucose dissolved in 250 mL water.', 'armGroupLabels': ['Type 2 DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Copenhagen', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital at Glostrup', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Stig K Holfort, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital, Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Stig Holfort, MD', 'oldOrganization': 'Glostrup University Hospital,Copenhagen'}}}}