Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction

Sponsor
Egymedicalpedia (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05884957
Collaborator
(none)
40
1
2
7
5.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nitric oxide synthase gene
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction: Effect of Tadalafil Therapy
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patients Group

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

Procedure: Nitric oxide synthase gene
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.

Active Comparator: Control Group

10 healthy people without erectile dysfunction

Procedure: Nitric oxide synthase gene
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.

Outcome Measures

Primary Outcome Measures

  1. ِAssessments of endothelial nitric oxide synthase In diabetes mellitus [24 hours]

    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 .

Secondary Outcome Measures

  1. Tadalafil 5milligram (tablets) therapy in diabetic patients [3 months from starting the therapy]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Qena Hospital Qinā Egypt

Sponsors and Collaborators

  • Egymedicalpedia

Investigators

  • Principal Investigator: Mohamed Hassan, Assist.Prof., Medical Biochemistry Department, Faculty of Medicine, South Valley University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Egymedicalpedia
ClinicalTrials.gov Identifier:
NCT05884957
Other Study ID Numbers:
  • Mona Hamza
First Posted:
Jun 1, 2023
Last Update Posted:
Jun 1, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2023