SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Genetic: SLMAP and EPO genetic polymorphism

• Registration Number: NCT05344690
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Study Start: 2022-05-20
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age >30-60
• Type 2 DM
• Duration of diabetes from 5-10 years
• Egyptian patients

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Exclusion Criteria

• Other ophthalmic diseases not related to diabetes

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cases	SLMAP and EPO genetic polymorphism	diabetic patients suffering from clinically confirmed diabetic retinopathy
controls	SLMAP and EPO genetic polymorphism	matched (based on gender and duration of diabetes) diabetic patients free from diabetic retinopathy will be recruited.

Primary Outcome Measures

Name	Time	Method
Association of SLMAP gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis	At baseline (upon confirmed diagnosis of diabetic retinopathy)	the odds ratio of being diagnosed with diabetic retinopathy in those with SLMAP rs17058639 single nucleotide polymorphism compared to wild type
Association of EPO gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis	At baseline (upon confirmed diagnosis of diabetic retinopathy)	The odds ratio of being diagnosed with diabetic retinopathy in those with EPO rs551238 single nucleotide polymorphism compared to wild type

Secondary Outcome Measures

Name	Time	Method
The association of confounding factors on the incidence of diabetic retinopathy	At baseline	A multiple logistic regression model will be fitted to assess the association of diabetic retinopathy to confounders (microalbuminuria, lipid profile, age, gender,...etc.)

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasseya, Egypt