Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-04-18 @ 10:53 PM
Study NCT ID:
NCT02770235
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2016-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007172', 'term': 'Erectile Dysfunction'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2016-05-11', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'erectile dysfunction and AGE levels', 'timeFrame': '2 hours', 'description': 'To evaluate the association between erectile dysfunction and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent', 'Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27847146', 'type': 'RESULT', 'citation': 'Kouidrat Y, Zaitouni A, Amad A, Diouf M, Desailloud R, Loas G, Lalau JD. Skin autofluorescence (a marker for advanced glycation end products) and erectile dysfunction in diabetes. J Diabetes Complications. 2017 Jan;31(1):108-113. doi: 10.1016/j.jdiacomp.2016.10.026. Epub 2016 Oct 29.'}]}, 'descriptionModule': {'briefSummary': 'In diabetics there is an abnormally increased production of AGEs due to hyperglycemia. An association was shown between AGE measured by biopsy (invasive) and DE patients with diabetes (increase of AGE level in the corpora cavernosa). To date no studies have explored the link between DE and the measure of AGE by a non-invasive method of Auto-fluorescence (AF) Skin (AGEReaderTM).\n\nIf the hypothesis of an association between DE and AGE measured by AF was checked, screening for erectile dysfunction and measurement of AGEs could help to improve the overall management of diabetic patient (including cardiovascular) and their quality of life.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes Type 2\n\nExclusion Criteria:\n\n* skin hyperpigmentation'}, 'identificationModule': {'nctId': 'NCT02770235', 'acronym': 'APGADEPD', 'briefTitle': 'Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of Advanced Glycation End-products (AGE) and the Erectile Dysfunction (DE) in Diabetic Patients', 'orgStudyIdInfo': {'id': 'PI2013_843_0021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DE assessment and AGE measurements', 'description': 'To evaluate the association between erectile dysfunction (DE) and AGE levels by using non-invasive measurement AGE-ReaderTM, in diabetic patients', 'interventionNames': ['Other: DE assessment', 'Other: AGE measurement']}], 'interventions': [{'name': 'DE assessment', 'type': 'OTHER', 'description': 'by a validated self-administered questionnaire: Index International erectile function (IIEF-15)', 'armGroupLabels': ['DE assessment and AGE measurements']}, {'name': 'AGE measurement', 'type': 'OTHER', 'description': 'By AGE-ReaderTM', 'armGroupLabels': ['DE assessment and AGE measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Jean-Daniel LALAU, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}