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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00880139
• Other study ID #: OPHT-171008
• Status: Terminated
• Phase: N/A
• First received: December 18, 2008
• Last updated: November 13, 2014
• Start date: June 2009
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Inflammation
• Retinal Diseases

Intervention

Procedure:
• Blood sampling
Determination of cytokine plasma levels (ELISA)
• Noninvasive measurement of systemic hemodynamics
performed once
• 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
• High resolution optical coherence tomography (OCT)
performed once

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma biomarkers for inflammation (CRP, TNF-a, IL-6, vWF, e-Selektin)		1 day	No
Primary	Perifoveal white cell blood flow (Blue field entoptic technique)		1 day	No
Primary	Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer)		1 day	No
Primary	Arteriolar to venous ratio		1 day	No
Secondary	Capillary blood glucose		1 day	No
Secondary	Stage of diabetic retinopathy		1 day	No
Secondary	Visual acuity		1 day	No
Secondary	Intraocular pressure		1 day	No
Secondary	Systolic/diastolic arterial blood pressure, pulse rate		1 day	No