Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes

Summary

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.

Conditions

• Diabetic Retinopathy
• Inflammation

Interventions

PROCEDURE

Blood sampling

Determination of cytokine plasma levels (ELISA)

PROCEDURE

Noninvasive measurement of systemic hemodynamics

performed once

PROCEDURE

Visual acuity assessment

ETDRS charts

DEVICE

Blue field entoptic technique (Blue field stimulator, BFS-2050)

performed once

PROCEDURE

Ophthalmic examination and fundus photography

7 + 1 standard fields

DEVICE

Retinal Vessel Analyzer (DVA)

Assessment of retinal vessel reactivity to stimulation with flickering light

DEVICE

High resolution optical coherence tomography (OCT)

performed once

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Berthold Pemp, MD · Department of Clinical Pharmacology, Medical University of Vienna

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2012-08-31

Completion

2012-09-30

Countries

• Austria

Study Locations