- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434362
Serum Endocan, Alarin, and Galanin-Like Peptide Levels in Diabetic Retinopathy
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Elaziğ
-
Elâzığ, Elaziğ, Turkey (Türkiye)
- Fethi Sekin City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
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.
Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.
|
|
Other: 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.
|
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.
Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.
|
|
Other: 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.
|
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.
Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.
|
|
Other: 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.
|
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.
Non-invasive optical coherence tomography imaging of the macula and peripapillary retinal nerve fiber layer using a Canon OCT device for structural retinal assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum Endocan Level
Time Frame: At baseline (preoperative blood sampling)
|
Serum endocan concentration measured using ELISA and compared across diabetic retinopathy stages.
|
At baseline (preoperative blood sampling)
|
|
Serum Alarin Level
Time Frame: At baseline
|
Serum alarin concentration measured by ELISA and analyzed according to diabetic retinopathy severity.
|
At baseline
|
|
Serum Galanin-Like Peptide Level
Time Frame: At baseline
|
Serum galanin-like peptide concentration measured using ELISA and compared between study groups.
|
At baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Eye Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Retinal Diseases
- Nutritional and Metabolic Diseases
- Diabetic Retinopathy
- Diabetes Mellitus
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Tomography
- Diagnostic Imaging
- Tomography, Optical
- Optical Imaging
- Tomography, Optical Coherence
- Blood Specimen Collection
Other Study ID Numbers
- EFSH-NIEC-2025-10-15
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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