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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00880139
First received: December 18, 2008
Last updated: November 30, 2009
Last verified: November 2009

December 18, 2008
November 30, 2009
December 2008
December 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00880139 on ClinicalTrials.gov Archive Site
  • 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 ]
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.
 
Recruiting
50
April 2010
December 2009   (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
Both
18 Years and older
No
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at
Austria
 
NCT00880139
OPHT-171008
Not Provided
Berthold Pemp, Department of Clinical Pharmacology, 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 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP