Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-25 @ 4:15 PM
Study NCT ID:
NCT05884957
Status:
COMPLETED
Last Update Posted:
2024-01-18
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ِAssessments of endothelial nitric oxide synthase In diabetes mellitus', 'timeFrame': '24 hours', 'description': 'About 2 milliliter of blood will be evacuated into EDTA containing tubes and will be stored at-80c till the time of genetic assay of nitric oxide synthase gene polymorphism using RELP - PCR technique .'}], 'secondaryOutcomes': [{'measure': 'Tadalafil 5milligram (tablets) therapy in diabetic patients', 'timeFrame': '3 months from starting the therapy', 'description': 'Evaluate the effect of endothelial nitric oxide synthase gene polymorphism on response to 5 milligram of Tadalafil (tablets) therapy in diabetic patients with erectile dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Erectile dysfunction (ED) is defined as penile erection that is insufficient and unsustainable for a satisfactory sexual performance.\n\nThe etiology of ED is multifactorial including chronic diseases such as hypertension, diabetes mellitus and coronary artery disease However, the main underlying cause is degenerative changes that result in endothelial dysfunction', 'detailedDescription': 'Diabetes leads to endothelial dysfunction and a pro-inflammatory state, which reduces the usability and activity of nitric oxide (NO). NO is a powerful force for sustaining penile blood flow.\n\nDiabetes is an estab¬lished risk factor for sexual dysfunction in men; a three-fold increased risk of erectile dysfunction (ED) was documented in diabetics compared with non-diabetic men.\n\nIn smooth muscles, NO activates guanyl cyclase and increases cyclic guanosine monophosphate (cGMP) concentration. cGMP activates certain intracellular protein kinases that phosphorylate receptor proteins. Activated protein kinases open the potassium channels and increase the influx of potassium and block the influx of calcium by inhibiting calcium channels. This leads to hyperpolarization and relaxation of smooth muscle. Reduced arteriolar resistance leads to sinusoidal spaces filled with blood. These enlarged sinusoids further increase the intracavernosal pressure by blocking the venous return and producing a rigid erection. cGMP is converted to GMP by phosphodiesterase, which is inhibited by phosphodiesterase 5 (PDE-5) inhibitors.\n\n(NO) has vasodilatory properties and balances RhoA/Rho-kinase-mediated vasoconstriction, which is a predominant mediator of the physiologic induction and maintenance of erections.\n\nEvidences show that functional polymorphisms within endothelial NO synthase (eNOS) gene interfere with normal erectile function.\n\nIn humans, the eNOS gene is located on chromosome 7q35-36 and consists of 26 exons spanning 21 kilobases (kb). Several polymorphisms of eNOS have been investigated. More frequently, investigated regions of this gene include a variable number of 27 bp tandem repeats in intron 4 (VNTR), G894T (rs1799983) polymorphism in exon 7 and a T-786C (rs2070744) polymorphism in the promoter region'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diabetic patients with ED.\n2. Using tadalafil 5mg\n\nExclusion Criteria:\n\n1. Patients with history of pelvic trauma or major pelvic surgical intervention.\n2. Patients with hypogonadism and hyperprolactinemia.\n3. Patients with chronic liver disease or cardio vascular system diseases.\n4. History of chronic intake of central nervous system, anti-androgen drugs or other drugs as Tramadol.\n5. Smokers.\n6. Patients with non-vasculogenic Erectile dysfunction'}, 'identificationModule': {'nctId': 'NCT05884957', 'briefTitle': 'Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction: Effect of Tadalafil Therapy', 'orgStudyIdInfo': {'id': 'Mona Hamza'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients Group (Nitric oxide Assesment)', 'description': 'Assessment of nitric oxide synthase gene polymorphism in diabetic patients with erectile dysfunction in 30 patients', 'interventionNames': ['Diagnostic Test: Nitric oxide synthase gene']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': '10 healthy people without erectile dysfunction', 'interventionNames': ['Diagnostic Test: Nitric oxide synthase gene']}], 'interventions': [{'name': 'Nitric oxide synthase gene', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biochemical assessment of serum nitric oxide level pre and post 5 mg tadalafil therapy in diabetic patients with erectile dysfunction and in normal healthy controls.', 'armGroupLabels': ['Control Group', 'Patients Group (Nitric oxide Assesment)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'facility': 'Qena Hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Mohamed Hassan, Assist.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Biochemistry Department, Faculty of Medicine, South Valley University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}