Serum and Corporal Irisin Level and Its Correlation With Erectile Function in Diabetic Obese Patients

NCT ID: NCT06696599

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2026-09-30

Brief Summary

Obese and diabetic men constitute a huge fraction of ED patients. There is established relation between both obesity ,diabetes and ED through multiple neuroendocrine and vascular players .

A limited number of serum biomarkers are available for ED with diabetic patients. These are biomarkers often used for endothelial dysfunction, inflammation and oxidative stress. Serum E-selectin, endothelial progenitor cell (EPC), endothelial micro particle (EMP), tumour necrosis factor / interleukin-10 (TNF-a / IL-10), nitric oxide (NO), MDA (malondialdehyde) and lipoprotein (a) are the most used biomarkers in this population.

Detailed Description

Obese and diabetic men constitute a huge fraction of ED patients. There is established relation between both obesity ,diabetes and ED through multiple neuroendocrine and vascular players .

A limited number of serum biomarkers are available for ED with diabetic patients. These are biomarkers often used for endothelial dysfunction, inflammation and oxidative stress. Serum E-selectin, endothelial progenitor cell (EPC), endothelial micro particle (EMP), tumour necrosis factor / interleukin-10 (TNF-a / IL-10), nitric oxide (NO), MDA (malondialdehyde) and lipoprotein (a) are the most used biomarkers in this population.

Irisin is a novel skeletal muscle- and adipose tissue-secreted peptide. It is conventionally regarded as an adipomyokine and is a cleaved fragment of Fibronectin type III domain containing protein 5 (FNDC5). It is involved in the browning of white adipose tissue, glucose tolerance, and reversing of metabolic disruptions.

Irisin exerts a direct vascular protective effect on endothelial function:- The mechanism for this protective effect of irisin appeared to be related AMP activated protein kinase and endothelial NO synthase (AMPK-eNOS) signaling pathway activation.Irisin enhanced NO production and phosphorylation of AMPK, Akt, and eNOS in endothelial cells.

According to a recently published study, The use of exogenous irisin is thought to alleviate endothelial dysfunction in T2DM by reducing oxidative / nitrative stresses. Therefore, it can be used in the future to eliminate the vascular complications of diabetes.Although the relationship between T2DM, endothelial dysfunction and irisin has been demonstrated in many previous studies.

Conditions

Serum and Corporal Irisin in Diabetic Patients With Erectile Dysfunction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Serum and corporal irisin in diabetic patients

Penil duplex ,serum irisin ,corporal irisin

Serum and corporal irisin

Intervention Type: PROCEDURE

measure serum and corporal irisin

Serum irisin in normal persons

Serum irisin

No interventions assigned to this group

Interventions

Serum and corporal irisin

measure serum and corporal irisin

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age of patients 30-50 years old .
• patients with type ll diabetes mellitus .
• patients on oral hypoglycemic medications .
• Non responders PDEI-5 ED patients

Exclusion Criteria

• Age of patients above 60 years old .
• patients with type l diabetes mellitus on insulin .
• patients with hypogonadism .

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Islam Mohamed Abdelrahman fahem

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Irisin in erectile dysfunction

Identifier Type: -

Identifier Source: org_study_id