Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-30 @ 1:26 AM
Study NCT ID:
NCT01771835
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of retinal venous pressure (RVP)', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Quantification of ET-1 in correlation with RVP', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'retinal venous pressure', 'endothelin-1'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '25793018', 'type': 'DERIVED', 'citation': 'Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.', 'detailedDescription': 'Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.\n\nIn ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with diabets mellitus type I or II, without diabetic retinopathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes mellitus type I or II\n* no diabetic retinopathy\n\nExclusion Criteria:\n\n* known diabetic retinopathy\n* acute or chronic inflammation of the eyes\n* narrow angle glaucoma\n* minority'}, 'identificationModule': {'nctId': 'NCT01771835', 'briefTitle': 'Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus', 'orgStudyIdInfo': {'id': '089-CYA-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes patients', 'description': 'Patients with diabetes mellitus type I + II, without diabetic retinopathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University of Basel, Dept. of Ophthalmology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Josef Flammer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Basel, Dept. of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}