Diabetic RetinopathyNCT07434362
Serum Endocan, Alarin, and Galanin-Like Peptide Levels in Diabetic Retinopathy
A study testing Venous Blood Sampling and Optical Coherence Tomography (OCT) in people with Diabetic Retinopathy and Diabetes Mellitus, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective cross-sectional study aims to evaluate the association between serum endocan, alarin, and galanin-like peptide levels and the stages of diabetic retinopathy (DR), as well as their relationship with optical coherence tomography (OCT) findings. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Retinopathy, Diabetes Mellitus, Retinal Microvascular Disease
- What is being tested?
- Venous Blood Sampling and Optical Coherence Tomography (OCT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 18 Feb 2026
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 70 years.
- Diagnosis of diabetes mellitus (for diabetic groups).
- For control group: absence of diabetes mellitus and no retinal or optic nerve pathology.
Who cannot join
- Presence of systemic or ocular inflammatory disease.
- Any ocular disease other than diabetic retinopathy that may affect the retina or optic nerve.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Serum Endocan, Alarin, and Galanin-Like Peptide Levels With Diabetic Retinopathy Stages and Optical Coherence Tomography (OCT) Findings
This prospective cross-sectional study aims to evaluate the association between serum endocan, alarin, and galanin-like peptide levels and the stages of diabetic retinopathy (DR), as well as their relationship with optical coherence tomography (OCT) findings.
A total of 120 participants will be included: 30 patients without diabetic retinopathy, 30 with non-proliferative diabetic retinopathy, 30 with proliferative diabetic retinopathy, and 30 healthy control subjects. In addition to routine preoperative blood sampling, an additional 5 mL of venous blood will be collected for biomarker analysis using ELISA. Macular and peripapillary retinal nerve fiber layer measurements will be obtained using OCT. Serum biomarker levels will be compared across DR stages and analyzed for correlation with OCT parameters.
- Being tested
- Venous Blood Sampling, Optical Coherence Tomography (OCT)
- Keywords
- Diabetic Retinopathy, Endocan, Alarin, Galanin-Like Peptide, Optical Coherence Tomography, Retinal Nerve Fiber Layer
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Blood SamplingProcedure or surgery
Collection of 5 mL of venous blood in addition to routine preoperative sampling for the measurement of serum endocan, alarin, and galanin-like peptide levels using ELISA.
Optical Coherence Tomography (OCT)Procedure or surgery
Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Mellitus Without Retinopathy | Other | Patients diagnosed with diabetes mellitus without clinical evidence of diabetic retinopathy. Participants will undergo OCT examination and additional venous blood sampling for biomarker analysis. Receives: Procedure: Venous Blood Sampling; Procedure: Optical Coherence Tomography (OCT) |
| Non-Proliferative Diabetic Retinopathy (NPDR) | Other | Patients with clinically diagnosed non-proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker measurement. Receives: Procedure: Venous Blood Sampling; Procedure: Optical Coherence Tomography (OCT) |
| Proliferative Diabetic Retinopathy (PDR) | Other | Patients with clinically diagnosed proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker analysis. Receives: Procedure: Venous Blood Sampling; Procedure: Optical Coherence Tomography (OCT) |
| Healthy Control Group | Other | Age-matched control participants without diabetes or retinal pathology who will undergo OCT examination and venous blood sampling for comparative biomarker evaluation. Receives: Procedure: Venous Blood Sampling; Procedure: Optical Coherence Tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Endocan Level
Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.
Measured: At baseline (preoperative blood sampling)
Serum Alarin Level
Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.
Measured: At baseline
Serum Galanin-Like Peptide Level
Serum galanin-like peptide concentration measured using ELISA and compared between study groups.
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 Feb 2026
- Study start30 Jan 2026
- Primary completion1 Feb 2026
- Study completion18 Feb 2026
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Keser, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434362
- Sponsor's protocol ID
- EFSH-NIEC-2025-10-15
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum Endocan, Alarin, and Galanin-Like Peptide Levels With Diabetic Retinopathy Stages and Optical Coherence Tomography (OCT) Findings
- ClinicalTrials.gov ID
- NCT07434362
- Acronym / sponsor ID
- EFSH-NIEC-2025-10-15
- Keywords
- Diabetic Retinopathy, Endocan, Alarin, Galanin-Like Peptide, Optical Coherence Tomography, Retinal Nerve Fiber Layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 18 Feb 2026 (actual)
- First posted
- 25 Feb 2026 (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.
This prospective cross-sectional study aims to evaluate the association between serum endocan, alarin, and galanin-like peptide levels and the stages of diabetic retinopathy (DR), as well as their relationship with optical coherence tomography (OCT) findings.
A total of 120 participants will be included: 30 patients without diabetic retinopathy, 30 with non-proliferative diabetic retinopathy, 30 with proliferative diabetic retinopathy, and 30 healthy control subjects. In addition to routine preoperative blood sampling, an additional 5 mL of venous blood will be collected for biomarker analysis using ELISA. Macular and peripapillary retinal nerve fiber layer measurements will be obtained using OCT. Serum biomarker levels will be compared across DR stages and analyzed for correlation with OCT parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes Mellitus Without Retinopathy | Other | Procedure: Venous Blood Sampling, Procedure: Optical Coherence Tomography (OCT)Patients diagnosed with diabetes mellitus without clinical evidence of diabetic retinopathy. Participants will undergo OCT examination and additional venous blood sampling for biomarker analysis. |
| Non-Proliferative Diabetic Retinopathy (NPDR) | Other | Procedure: Venous Blood Sampling, Procedure: Optical Coherence Tomography (OCT)Patients with clinically diagnosed non-proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker measurement. |
| Proliferative Diabetic Retinopathy (PDR) | Other | Procedure: Venous Blood Sampling, Procedure: Optical Coherence Tomography (OCT)Patients with clinically diagnosed proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker analysis. |
| Healthy Control Group | Other | Procedure: Venous Blood Sampling, Procedure: Optical Coherence Tomography (OCT)Age-matched control participants without diabetes or retinal pathology who will undergo OCT examination and venous blood sampling for comparative biomarker evaluation. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40 to 70 years.
- Diagnosis of diabetes mellitus (for diabetic groups).
- For control group: absence of diabetes mellitus and no retinal or optic nerve pathology.
Key exclusion criteria (2 listed)
- Presence of systemic or ocular inflammatory disease.
- Any ocular disease other than diabetic retinopathy that may affect the retina or optic nerve.
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 |
|---|---|---|
| Venous Blood SamplingCollection of 5 mL of venous blood in addition to routine preoperative sampling for the measurement of serum endocan, alarin, and galanin-like peptide levels using ELISA. | Procedure or surgery | Diabetes Mellitus Without Retinopathy, Healthy Control Group, Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) |
| Optical Coherence Tomography (OCT)Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment. | Procedure or surgery | Diabetes Mellitus Without Retinopathy, Healthy Control Group, Non-Proliferative Diabetic Retinopathy (NPDR), Proliferative Diabetic Retinopathy (PDR) |
Primary outcome
Serum Endocan Level
Time frame: At baseline (preoperative blood sampling)
Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.
Serum Alarin Level
Time frame: At baseline
Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.
Serum Galanin-Like Peptide Level
Time frame: At baseline
Serum galanin-like peptide concentration measured using ELISA and compared between study groups.
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 25 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venous Blood Sampling and Optical Coherence Tomography (OCT) in people with Diabetic Retinopathy and Diabetes Mellitus, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 25 Feb 2026. 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 Turkey (Türkiye). 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?
Serum Endocan Level (time frame: At baseline (preoperative blood sampling)). The study lists 3 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 25 Feb 2026.