Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-28 @ 10:33 PM
Study NCT ID:
NCT01107132
Status:
UNKNOWN
Last Update Posted:
2010-04-20
First Post:
2010-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '• Fluorescein Angiography\n\n1. Investigation and documentation of the retinal and choroidal vascular systems integrity by intravenous administration of sodium fluorescein\n2. FA images are recorded in a central database with restricted accesses and are routinely analyzed by the eye specialist'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2010-04-19', 'studyFirstSubmitDate': '2010-04-18', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Non-Proliferative Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'In Type 2 Diabetes mellitus patients we will:\n\n1. quantify vasculopathy and blood-retinal barrier (BRB) leakage\n2. measure blood-brain barrier (BBB) permeability and neuroanatomical changes\n3. correlate BRB pathology with BBB breakdown, inflammatory markers and neuropsychiatric sequela'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 Diabetes Mellitus Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) who are in the clinical database of the ophthalmologic department , above 18 years old at the time of diagnosis and underwent FA examination in the past three years\n2. Patients which their medical records are available via a computerized data base\n\nControl group:\n\n1. T2DM patients who are in the clinical database of the ophthalmologic department\n2. Above 18 years old at the time of diagnosis\n3. Underwent FA examination in the past three years and their examination was interpreted as "normal", i.e. without suspected diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT01107132', 'briefTitle': 'Blood-retinal Barrier Imaging and Neuropsychiatric Sequela in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'Blood-retinal Barrier Imaging in Type 2 Diabetes Mellitus: a Window for Blood-brain Barrier Breakdown and Neuropsychiatric Sequela', 'orgStudyIdInfo': {'id': 'SOR495710ctil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetic Retinopathy', 'description': 'T2DM Patient suffering from Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'contacts': [{'name': 'Hadar Shalev, M.D', 'role': 'CONTACT', 'email': 'shalev@bgu.ac.il'}, {'name': 'Hadar Shalev, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'centralContacts': [{'name': 'Hadar Shalev, M.D', 'role': 'CONTACT', 'email': 'shalev@bgu.ac.il', 'phone': '972506996696'}], 'overallOfficials': [{'name': 'Hadar Shalev, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hadar Shalev, M.D', 'oldOrganization': 'Soroka University Medical Center'}}}}