A Cross-sectional Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
Sponsor study identifier
observational
33
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
September 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2008
Actual (reported)April 13, 2009
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 2012
Actual (reported)September 2012
Actual (reported)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
Capillary blood glucose
1 day
Stage of diabetic retinopathy
1 day
Visual acuity
1 day
Intraocular pressure
1 day
Systolic/diastolic arterial blood pressure, pulse rate
1 day
Determination of cytokine plasma levels (ELISA)
performed once
outpatients
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Berthold Pemp, MD
Department of Clinical Pharmacology, Medical University of Vienna
33 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2008
First Posted
April 13, 2009
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
ETDRS charts
performed once
7 + 1 standard fields
Assessment of retinal vessel reactivity to stimulation with flickering light
performed once
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Primary Completion
August 2012
Actual (reported)Study Completion
September 2012
Actual (reported)Last Updated
November 14, 2014
Record last verified: 2014-11
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Source: ClinicalTrials.gov.
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