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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00880139
First Posted: April 13, 2009
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
December 18, 2008
April 13, 2009
November 14, 2014
June 2009
August 2012   (Final data collection date for primary outcome measure)
  • Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin) [ Time Frame: 1 day ]
  • Perifoveal white cell blood flow (Blue field entoptic technique) [ Time Frame: 1 day ]
  • Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer) [ Time Frame: 1 day ]
  • Arteriolar to venous ratio [ Time Frame: 1 day ]
Same as current
Complete list of historical versions of study NCT00880139 on ClinicalTrials.gov Archive Site
  • Capillary blood glucose [ Time Frame: 1 day ]
  • Stage of diabetic retinopathy [ Time Frame: 1 day ]
  • Visual acuity [ Time Frame: 1 day ]
  • Intraocular pressure [ Time Frame: 1 day ]
  • Systolic/diastolic arterial blood pressure, pulse rate [ Time Frame: 1 day ]
Same as current
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
outpatients
  • Diabetic Retinopathy
  • Inflammation
  • 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
    Other Names:
    • Blue field stimulator
    • BFS-2050
  • 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
    Other Name: DVA
  • Device: High resolution optical coherence tomography (OCT)
    performed once
    Other Name: OCT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
September 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00880139
OPHT-171008
Not Provided
Not Provided
Not Provided
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Berthold Pemp, MD Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
November 2014