Diabetic RetinopathyNCT05344690
SLMAP and EPO Genetic Polymorphism in Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- SLMAP and EPO genetic polymorphism
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Age >30-60
- Type 2 DM
- Duration of diabetes from 5-10 years
- Egyptian patients
Who cannot join
- Other ophthalmic diseases not related to diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Retinopathy
- Being tested
- SLMAP and EPO genetic polymorphism
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLMAP and EPO genetic polymorphismGenetic
Presence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms
| Study group | Role | What they receive |
|---|---|---|
| cases | diabetic patients suffering from clinically confirmed diabetic retinopathy Receives: Genetic: SLMAP and EPO genetic polymorphism | |
| controls | matched (based on gender and duration of diabetes) diabetic patients free from diabetic retinopathy will be recruited. Receives: Genetic: SLMAP and EPO genetic polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At baseline (upon confirmed diagnosis of diabetic retinopathy)
Secondary outcomes (1)
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.)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start20 May 2022
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sayed Fouad, Ain Shams University
- Investigators
- Lamiaa M El Wakeel, PhD, Study chair, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344690
- Sponsor's protocol ID
- RHDIRB2020110301 REC 72
- Status last verified
- Feb 2024
- First submitted
- 19 Apr 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05344690
- Acronym / sponsor ID
- RHDIRB2020110301 REC 72
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Genetic: SLMAP and EPO genetic polymorphismdiabetic patients suffering from clinically confirmed diabetic retinopathy |
| controls | – | Genetic: SLMAP and EPO genetic polymorphismmatched (based on gender and duration of diabetes) diabetic patients free from diabetic retinopathy will be recruited. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Age >30-60
- Type 2 DM
- Duration of diabetes from 5-10 years
- Egyptian patients
Key exclusion criteria (1 listed)
- Other ophthalmic diseases not related to diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLMAP and EPO genetic polymorphismPresence of EPO gene SNP rs551238 and SLMAP rs17058639 gene polymorphisms | Genetic | cases, controls |
Primary outcome
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
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
1 secondary outcome
The association of confounding factors on the incidence of diabetic retinopathy
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa M El Wakeel, PhD study chair
Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of SLMAP gene polymorphism and the risk of confirmed diabetic retinopathy diagnosis (time frame: At baseline (upon confirmed diagnosis of diabetic retinopathy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.