Association of Serum Endocan, Alarin, and Galanin-Like Peptide Levels With Diabetic Retinopathy Stages and Optical Coherence Tomography (OCT) Findings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum Endocan Level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Presence of systemic or ocular inflammatory disease.
- •Any ocular disease other than diabetic retinopathy that may affect the retina or optic nerve.
研究组 & 干预措施
Diabetes Mellitus Without Retinopathy
Patients diagnosed with diabetes mellitus without clinical evidence of diabetic retinopathy. Participants will undergo OCT examination and additional venous blood sampling for biomarker analysis.
干预措施: Venous Blood Sampling (Procedure)
Diabetes Mellitus Without Retinopathy
Patients diagnosed with diabetes mellitus without clinical evidence of diabetic retinopathy. Participants will undergo OCT examination and additional venous blood sampling for biomarker analysis.
干预措施: Optical Coherence Tomography (OCT) (Procedure)
Non-Proliferative Diabetic Retinopathy (NPDR)
Patients with clinically diagnosed non-proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker measurement.
干预措施: Venous Blood Sampling (Procedure)
Non-Proliferative Diabetic Retinopathy (NPDR)
Patients with clinically diagnosed non-proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker measurement.
干预措施: Optical Coherence Tomography (OCT) (Procedure)
Proliferative Diabetic Retinopathy (PDR)
Patients with clinically diagnosed proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker analysis.
干预措施: Venous Blood Sampling (Procedure)
Proliferative Diabetic Retinopathy (PDR)
Patients with clinically diagnosed proliferative diabetic retinopathy who will undergo OCT examination and additional venous blood sampling for serum biomarker analysis.
干预措施: Optical Coherence Tomography (OCT) (Procedure)
Healthy Control Group
Age-matched control participants without diabetes or retinal pathology who will undergo OCT examination and venous blood sampling for comparative biomarker evaluation.
干预措施: Venous Blood Sampling (Procedure)
Healthy Control Group
Age-matched control participants without diabetes or retinal pathology who will undergo OCT examination and venous blood sampling for comparative biomarker evaluation.
干预措施: Optical Coherence Tomography (OCT) (Procedure)
结局指标
主要结局
Serum Endocan Level
时间窗: At baseline (preoperative blood sampling)
Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.
Serum Alarin Level
时间窗: At baseline
Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.
Serum Galanin-Like Peptide Level
时间窗: At baseline
Serum galanin-like peptide concentration measured using ELISA and compared between study groups.
次要结局
未报告次要终点
研究者
Sinem Keser
Principal Investigator
Elazıg Fethi Sekin Sehir Hastanesi