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

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

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.

Study Overview

• Status: Terminated
• Conditions: Inflammation; Diabetic Retinopathy
• Intervention / Treatment: 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
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Berthold Pemp, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: April 10, 2009
• First Posted (Estimate): April 13, 2009

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Inflammation; Cytokines; Diabetes mellitus, type 1; Vascular reactivity
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Inflammation; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: OPHT-171008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No