Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 8:47 AM
Study NCT ID:
NCT01049750
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-15', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-13', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of erectile dysfunction', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}, {'measure': 'Description of erectile disfunction markers', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}, {'measure': 'Evaluation of diabetic neuropathy in patients with erectile dysfunction', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}], 'secondaryOutcomes': [{'measure': 'Metalloproteinases 2 and 9', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}, {'measure': 'Insulin-sensitivity index (HOMA index)', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}, {'measure': 'Glycemic control', 'timeFrame': 'Baseline (time 0); 3 months; 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'male', 'erectile dysfunction'], 'conditions': ['Type 2 Diabetic Patients', 'Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '22572549', 'type': 'RESULT', 'citation': "Derosa G, Tinelli C, D'Angelo A, Ferrara G, Bonaventura A, Bianchi L, Romano D, Fogari E, Maffioli P. Glyco-metabolic profile among type 2 diabetic patients with erectile dysfunction. Endocr J. 2012;59(7):611-9. doi: 10.1507/endocrj.ej12-0117. Epub 2012 May 26."}, {'pmid': '25747572', 'type': 'RESULT', 'citation': "Derosa G, Romano D, Tinelli C, D'Angelo A, Maffioli P. Prevalence and associations of erectile dysfunction in a sample of Italian males with type 2 diabetes. Diabetes Res Clin Pract. 2015 May;108(2):329-35. doi: 10.1016/j.diabres.2015.01.037. Epub 2015 Feb 7."}]}, 'descriptionModule': {'briefSummary': 'The investigators evaluated 250 male, type 2 diabetic patients, aged 18-80 years. They will undergo IIEF (International Index of Erectile Function), SAS of Zung (self-rating anxiety state)and SDS of Zung (self-rating depression scale)questionnaires. The investigators will evaluate anthropometric and biochemical parameters, dysautonomic function index, IMT (Intima Media Thickness) index, and fundus oculi examen. Furthermore, the investigators will perform MNSI (Michigan Neuropathy Screening Instrument) and NDS (Neuropathy Disability Score)questionnaires.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'males with type 2 diabetes mellitus', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* type 1 diabetes mellitus\n* \\< 18 years old\n* anatomic abnormalities of the penis\n* patients taking erectile dysfunction therapy at the moment of the enrollment'}, 'identificationModule': {'nctId': 'NCT01049750', 'briefTitle': 'Prevalence and Risk Factors of Erectile Dysfunction in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'orgStudyIdInfo': {'id': '20090001127'}, 'secondaryIdInfos': [{'id': 'P-20090002836', 'type': 'REGISTRY', 'domain': '20090002304'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'type 2 diabetic patients', 'description': 'males; type 2 diabetic patients', 'interventionNames': ['Other: type 2 diabetic patients']}], 'interventions': [{'name': 'type 2 diabetic patients', 'type': 'OTHER', 'description': 'males; type 2 diabetic patients', 'armGroupLabels': ['type 2 diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia - Fondazione IRCCS Policlinico San Matteo - Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}