Serum Endocan, Alarin, and Galanin-Like Peptide Levels in Diabetic Retinopathy

NCT07434362 — Not applicable, Completed, 90 participants, Elazıg Fethi Sekin Sehir Hastanesi

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Association of Serum Endocan, Alarin, and Galanin-Like Peptide Levels With Diabetic Retinopathy Stages and Optical Coherence Tomography (OCT) Findings

Registry	NCT07434362
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, diagnostic
Enrollment	90 (Actual)
Sponsor	Elazıg Fethi Sekin Sehir Hastanesi (Other)
Conditions	Diabetic Retinopathy, Diabetes Mellitus, Retinal Microvascular Disease
Interventions	Venous Blood Sampling, Optical Coherence Tomography (OCT) (Procedure)
Dates	start 2026-01-30, primary completion 2026-02-01, completion 2026-02-18, first posted 2026-02-25, last updated 2026-02-25
Locations	1 site in Turkey (Türkiye)

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

Venous Blood Sampling (Procedure): 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): Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.

+Outcome measures

Primary outcomes

Serum Endocan Level [At baseline (preoperative blood sampling)]: Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.
Serum Alarin Level [At baseline]: Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.
Serum Galanin-Like Peptide Level [At baseline]: Serum galanin-like peptide concentration measured using ELISA and compared between study groups.

+Eligibility

Sex: All, ages: 40 Years to 70 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Presence of systemic or ocular inflammatory disease.
* Any ocular disease other than diabetic retinopathy that may affect the retina or optic nerve.

+Locations (1)

Facility	City	Country	Status
Fethi Sekin City Hospital	Elâzığ, Elaziğ	Turkey (Türkiye)