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

November 19, 2024 updated by: Islam Mohamed Abdelrahman fahem, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Cross sectional

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Serum and corporal irisin in diabetic patients
Penil duplex ,serum irisin ,corporal irisin
Procedure: Serum and corporal irisin
measure serum and corporal irisin
Serum irisin in normal persons
Serum irisin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between irisin and erectile function in 50 patients 40 patients complaint from erectile dysfunction and 10 patients have good erection
Time Frame: 2 years
Measurement serum and corporal irisin in diabetic patients with erectile dysfunction
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Irisin in erectile dysfunction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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