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SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05344690
Collaborator
(none)
180
Enrollment
1
Location
6.4
Anticipated Duration (Months)
28.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: SLMAP and EPO genetic polymorphism

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 Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
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
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Hospitals Cairo Abbasseya Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

  • Study Chair: Lamiaa M El Wakeel, PhD, Faculty of Pharmacy, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rana Sayed Fouad, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05344690
Other Study ID Numbers:
  • RHDIRB2020110301 REC 72
First Posted:
Apr 25, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy

Study Results

No Results Posted as of Jun 15, 2022