Clinical trial NCT05884957: Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction
Official title: Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction: Effect of Tadalafil Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Diabetes Mellitus
Lead sponsor: Egymedicalpedia
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Diabetes 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.

In 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.

(NO) has vasodilatory properties and balances RhoA/Rho-kinase-mediated vasoconstriction, which is a predominant mediator of the physiologic induction and maintenance of erections.

Evidences show that functional polymorphisms within endothelial NO synthase (eNOS) gene interfere with normal erectile function.

In 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

Eligibility criteria: Inclusion Criteria:

1. Diabetic patients with ED.
2. Using tadalafil 5mg

Exclusion Criteria:

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

Primary outcomes:
measure: ِAssessments of endothelial nitric oxide synthase In diabetes mellitus
timeFrame: 24 hours
Secondary outcomes:
measure: Tadalafil 5milligram (tablets) therapy in diabetic patients
timeFrame: 3 months from starting the therapy
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Qena Hospital
Study officials:
affiliation: Medical Biochemistry Department, Faculty of Medicine, South Valley University
name: Mohamed Hassan, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References: