SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy

February 6, 2024 updated by: Rana Sayed Fouad, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasseya
      • Cairo, Abbasseya, Egypt
        • Ain Shams University Hospitals

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All diabetic patients registered to the outpatient clinic of the Endocrinology Unit will be assessed for eligibility followed by screening for diabetic retinopathy by fundoscopic examination Those with diabetic retinopathy will be assigned to the case group while matched diabetic patients free from diabetic retinopathy will be assigned to the control group.

Description

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 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
cases
diabetic patients suffering from clinically confirmed diabetic retinopathy
Genetic: SLMAP and EPO genetic polymorphism
Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms
controls
matched (based on gender and duration of diabetes) diabetic patients free from diabetic retinopathy will be recruited.
Genetic: SLMAP and EPO genetic polymorphism
Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of SLMAP gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis
Time Frame: 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
At baseline (upon confirmed diagnosis of diabetic retinopathy)
Association of EPO gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis
Time Frame: 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
At baseline (upon confirmed diagnosis of diabetic retinopathy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association of confounding factors on the incidence of diabetic retinopathy
Time Frame: 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.)
At baseline

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Chair: Lamiaa M El Wakeel, PhD, Faculty of Pharmacy, Ain Shams 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 (Actual)

May 20, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHDIRB2020110301 REC 72

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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