Study Investigating the Levels and Effects of Low-Grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00880139

Purpose

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.

Condition	Intervention
Diabetic Retinopathy Inflammation	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
Study Design:	Cohort, Cross-Sectional
Official Title:	A Cross-Sectional Study Investigating the Levels and Effects of Low-Grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Diabetic Eye Problems Retinal Disorders

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Perifoveal white cell blood flow (Blue field entoptic technique) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Arteriolar to venous ratio [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Capillary blood glucose [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Stage of diabetic retinopathy [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Visual acuity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Intraocular pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Systolic/diastolic arterial blood pressure, pulse rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Determination of cytokine plasma levels (ELISA)

performed once

ETDRS charts

performed once

7 + 1 standard fields

Assessment of retinal vessel reactivity to stimulation with flickering light

performed once

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

outpatients

Criteria

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
Moderate to 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880139

Contacts

Contact: Gerhard Garhoefer, MD

+43140400 ext 2981

gerhard.garhoefer@meduniwien.ac.at

Locations

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

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Berthold Pemp, MD

Department of Clinical Pharmacology, Medical University of Vienna

More Information

No publications provided

Responsible Party:	Department of Clinical Pharmacology, Medical University of Vienna ( Berthold Pemp )
Study ID Numbers:	OPHT-171008
Study First Received:	December 18, 2008
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00880139 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:

Diabetes mellitus, type 1
Inflammation
Cytokines
Vascular reactivity

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Diabetes Mellitus Type 1
Inflammation

Diabetic Angiopathies
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Retinal Diseases
Diabetes Complications

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Inflammation

Diabetic Angiopathies
Diabetic Retinopathy
Pathologic Processes
Diabetes Mellitus, Type 1
Cardiovascular Diseases
Glucose Metabolism Disorders
Diabetes Complications
Retinal Diseases

ClinicalTrials.gov processed this record on September 04, 2009