Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-01 @ 1:21 PM
Study NCT ID:
NCT00527995
Status:
COMPLETED
Last Update Posted:
2007-09-11
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2003-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-09-10', 'studyFirstSubmitDate': '2007-09-10', 'studyFirstSubmitQcDate': '2007-09-10', 'lastUpdatePostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.', 'timeFrame': '60 minutes'}], 'secondaryOutcomes': [{'measure': 'Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 35-70\n* type 2 diabetes mellitus\n* impotence\n* with and without hypertension, hypercholesteremia\n\nExclusion Criteria:\n\n* patients with history of cardiovascular and malignant disease,\n* advanced nephropathy (creatinine≥2.2mg/dl)\n* hepatopathy (liver enzymes higher than the double of normal values)\n* patients taking nitrates\n* CHF: NYHA \\> II\n* Stable angina: CCS \\> II'}, 'identificationModule': {'nctId': 'NCT00527995', 'briefTitle': 'Acute Effects of Sildenafil on Endothelial Function in People With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Ruhr University of Bochum'}, 'officialTitle': 'Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'Sildenafil_ED_2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': 'Orally administered, Sildenafil 100mg, unique administration'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Alin Stirban, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart and Diabetes Center NRW'}, {'name': 'Dan Ziegler, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'German Diabetes Center Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruhr University of Bochum', 'class': 'OTHER'}}}}