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NCT05344690 Clinical Trial

SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

Official title:
Evaluation of the Relationship Between SLMAP and EPO Genetic Polymorphism and the Risk of Diabetic Retinopathy in Egyptian Diabetic Patients: A Case-Control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05344690
Other study ID # RHDIRB2020110301 REC 72
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2022
Est. completion date June 30, 2023

Study information
Verified date February 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A case-control study to assess the association between the risk of diabetic retinopathy in Egyptians and genetic polymorphism of both EPO and SLMAP genes.

Description:

Traditional environmental risk factors, such as glycemic control and duration of diabetes, failed to fully explain why some individuals remain protected while others progress to severe diabetic retinopathy. Several studies suggest variations in diabetic retinopathy prevalence depending on racial background and genetic polymorphism.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date June 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - Age >30-60 - Type 2 DM - Duration of diabetes from 5-10 years - Egyptian patients Exclusion Criteria: - Other ophthalmic diseases not related to diabetes

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• SLMAP and EPO genetic polymorphism
Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms

Locations
Country Name City State
Egypt Ain Shams University Hospitals Cairo Abbasseya

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association of SLMAP gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis the odds ratio of being diagnosed with diabetic retinopathy in those with SLMAP rs17058639 single nucleotide polymorphism compared to wild type At baseline (upon confirmed diagnosis of diabetic retinopathy)
Primary Association of EPO gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis The odds ratio of being diagnosed with diabetic retinopathy in those with EPO rs551238 single nucleotide polymorphism compared to wild type At baseline (upon confirmed diagnosis of diabetic retinopathy)
Secondary The association of confounding factors on the incidence of diabetic retinopathy A multiple logistic regression model will be fitted to assess the association of diabetic retinopathy to confounders (microalbuminuria, lipid profile, age, gender,...etc.) At baseline
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