Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction

NCT05884957 | Completed DMC

• 1 other identifier: Mona Hamza
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Erectile dysfunction (ED) is defined as penile erection that is insufficient and unsustainable for a satisfactory sexual performance. The 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

Conditions

Erectile Dysfunction; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• ِAssessments of endothelial nitric oxide synthase In diabetes mellitus

  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 .

  24 hours

Secondary Outcomes (1)

• Tadalafil 5milligram (tablets) therapy in diabetic patients

  3 months from starting the therapy

Study Arms (2)

Patients Group (Nitric oxide Assesment)

ACTIVE COMPARATOR

Assessment of nitric oxide synthase gene polymorphism in diabetic patients with erectile dysfunction in 30 patients

Diagnostic Test: Nitric oxide synthase gene

Control Group

PLACEBO COMPARATOR

10 healthy people without erectile dysfunction

Diagnostic Test: Nitric oxide synthase gene

Interventions

Nitric oxide synthase gene DIAGNOSTIC_TEST

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.

Control Group; Patients Group (Nitric oxide Assesment)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients with ED.
• Using tadalafil 5mg

You may not qualify if:

• Patients with history of pelvic trauma or major pelvic surgical intervention.
• Patients with hypogonadism and hyperprolactinemia.
• Patients with chronic liver disease or cardio vascular system diseases.
• History of chronic intake of central nervous system, anti-androgen drugs or other drugs as Tramadol.
• Smokers.
• Patients with non-vasculogenic Erectile dysfunction

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Qena Hospital

Qina, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohamed Hassan, Assist.Prof.

  Medical Biochemistry Department, Faculty of Medicine, South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 1, 2023
• Study Start: June 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)