NCT05344690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

April 19, 2022

Last Update Submit

February 6, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • The association of confounding factors on the incidence of diabetic retinopathy

    At baseline

Study Arms (2)

cases

diabetic patients suffering from clinically confirmed diabetic retinopathy

Genetic: SLMAP and EPO genetic polymorphism

controls

matched (based on gender and duration of diabetes) diabetic patients free from diabetic retinopathy will be recruited.

Genetic: SLMAP and EPO genetic polymorphism

Interventions

Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms

casescontrols

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Other ophthalmic diseases not related to diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasseya, Egypt

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Lamiaa M El Wakeel, PhD

    Faculty of Pharmacy, Ain Shams University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 25, 2022

Study Start

May 20, 2022

Primary Completion

April 30, 2023

Study Completion

June 30, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations