Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00880139|
Recruitment Status : Terminated
First Posted : April 13, 2009
Last Update Posted : November 14, 2014
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.
|Condition or disease||Intervention/treatment|
|Diabetic Retinopathy Inflammation||Procedure: Blood sampling Procedure: Noninvasive measurement of systemic hemodynamics Procedure: Visual acuity assessment Device: Blue field entoptic technique (Blue field stimulator, BFS-2050) Procedure: Ophthalmic examination and fundus photography Device: Retinal Vessel Analyzer (DVA) Device: High resolution optical coherence tomography (OCT)|
|Study Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||A Cross-sectional Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Procedure: Blood sampling
- Blue field stimulator
- Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin) [ Time Frame: 1 day ]
- Perifoveal white cell blood flow (Blue field entoptic technique) [ Time Frame: 1 day ]
- Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer) [ Time Frame: 1 day ]
- Arteriolar to venous ratio [ Time Frame: 1 day ]
- Capillary blood glucose [ Time Frame: 1 day ]
- Stage of diabetic retinopathy [ Time Frame: 1 day ]
- Visual acuity [ Time Frame: 1 day ]
- Intraocular pressure [ Time Frame: 1 day ]
- Systolic/diastolic arterial blood pressure, pulse rate [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880139
|Department of Clinical Pharmacology, Medical University of Vienna|
|Principal Investigator:||Berthold Pemp, MD||Department of Clinical Pharmacology, Medical University of Vienna|