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Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction, Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nitric oxide synthase gene
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Diabetic patients with ED. Using tadalafil 5mg Exclusion Criteria: 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

Sites / Locations

  • Qena HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Patients Group (Nitric oxide Assesment)

Control Group

Arm Description

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

10 healthy people without erectile dysfunction

Outcomes

Primary Outcome Measures

ِ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 .

Secondary Outcome Measures

Tadalafil 5milligram (tablets) therapy in diabetic patients
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.

Full Information

First Posted
May 10, 2023
Last Updated
October 14, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05884957
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients Group (Nitric oxide Assesment)
Arm Type
Active Comparator
Arm Description
Assessment of nitric oxide synthase gene polymorphism in diabetic patients with erectile dysfunction in 30 patients
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
10 healthy people without erectile dysfunction
Intervention Type
Diagnostic Test
Intervention Name(s)
Nitric oxide synthase gene
Intervention 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.
Primary Outcome Measure Information:
Title
ِAssessments of endothelial nitric oxide synthase In diabetes mellitus
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 .
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Tadalafil 5milligram (tablets) therapy in diabetic patients
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.
Time Frame
3 months from starting the therapy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diabetic patients with ED. Using tadalafil 5mg Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Ibrahim, Assist.Prof.
Phone
01011524245
Email
hassan.mohamed@med.svu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan, Assist.Prof.
Organizational Affiliation
Medical Biochemistry Department, Faculty of Medicine, South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qena Hospital
City
Qinā
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Hamza, MSc
Phone
01005759289
Email
monahamzaa10@gmail.com
First Name & Middle Initial & Last Name & Degree
Eisa Hegazy, Assist.Prof.
Phone
01094337795
Email
eisa_mohamed4152@med.svu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction

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