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There is much evidence that localized low grade inflammatory processes may contribute to the microvascular complications of type 1 and type 2 diabetes mellitus including sight-threatening diabetic retinopathy. Some biomarkers for inflammation have been found to be elevated in diabetes patients and correlations between those biomarkers and the severity of diabetic complications have been found in the last years. The relation between this low grade inflammation and the microvascular changes observed in diabetic retinopathy is, however, not well characterized.
In the present study patients with different stages of non-proliferative diabetic retinopathy will be included. Several markers of inflammation will be measured from blood samples. These markers will be related to vascular factors including flicker-induced vasodilatation as a marker of endothelial dysfunction and perifoveal leukocyte velocity and density as measured with the blue field entoptic phenomenon. In addition, the ophthalmologic status of the patients will be assessed according to the Modified Airlie House classification.
A multiple regression model will be employed to study the association between the different methods.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Determination of cytokine plasma levels (ELISA) | ||
| Noninvasive measurement of systemic hemodynamics | Procedure | performed once | ||
| Visual acuity assessment | Procedure | ETDRS charts | ||
| Blue field entoptic technique (Blue field stimulator, BFS-2050) | Device | performed once |
| |
| Ophthalmic examination and fundus photography | Procedure | 7 + 1 standard fields | ||
| Retinal Vessel Analyzer (DVA) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin) | 1 day | |
| Perifoveal white cell blood flow (Blue field entoptic technique) | 1 day | |
| Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer) | 1 day | |
| Arteriolar to venous ratio | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Capillary blood glucose | 1 day | |
| Stage of diabetic retinopathy | 1 day | |
| Visual acuity |
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Inclusion Criteria:
Exclusion Criteria:
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outpatients
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Pemp, MD | Department of Clinical Pharmacology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | Austria |
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Assessment of retinal vessel reactivity to stimulation with flickering light |
|
| High resolution optical coherence tomography (OCT) | Device | performed once |
|
| 1 day |
| Intraocular pressure | 1 day |
| Systolic/diastolic arterial blood pressure, pulse rate | 1 day |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D007249 | Inflammation |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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