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Not yet recruiting NCT06696599

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

Observational Serum and Corporal Irisin in Diabetic Patients With Erectile Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serum and corporal irisin.
Who it may be relevant to
Registry conditions: Serum and Corporal Irisin in Diabetic Patients With Erectile Dysfunction. Basic parameters: 30 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Serum and corporal irisin
    measure serum and corporal irisin

Primary outcome measures

  • 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]

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06696599 · Irisin in erectile dysfunction

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗