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

NCT ID: NCT00880139

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Blood sampling

Determination of cytokine plasma levels (ELISA)

Intervention Type PROCEDURE

Noninvasive measurement of systemic hemodynamics

performed once

Intervention Type PROCEDURE

Visual acuity assessment

ETDRS charts

Intervention Type PROCEDURE

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

performed once

Intervention Type DEVICE

Ophthalmic examination and fundus photography

7 + 1 standard fields

Intervention Type PROCEDURE

Retinal Vessel Analyzer (DVA)

Assessment of retinal vessel reactivity to stimulation with flickering light

Intervention Type DEVICE

High resolution optical coherence tomography (OCT)

performed once

Intervention Type DEVICE

Other Intervention Names

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Blue field stimulator BFS-2050 DVA OCT

Eligibility Criteria

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Inclusion Criteria

* Patients with type 1 diabetes mellitus with duration of \> 1 year
* Men and women, age ≥ 18, nonsmokers
* Body mass index between 16 and 30 kg/m²
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant or diabetes-related
* Mild, moderate or severe non-proliferative diabetic retinopathy

Exclusion Criteria

* Abuse of drugs or alcoholic beverages
* Participation in a clinical trial in the 3 weeks preceding the study
* Treatment with anti-inflammatory drugs in the 3 weeks before the study day
* Symptoms of a clinically relevant illness in the 3 weeks before the study day
* Blood donation or equivalent blood loss in the 3 weeks before the study day
* Other ocular pathologies than non-proliferative diabetic retinopathy
* Ametropia \> 6 dpt
* History or family history of epilepsy
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berthold Pemp, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-171008

Identifier Type: -

Identifier Source: org_study_id