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
  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: Observational Model: Cohort
Time Perspective: 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:


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:
    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
  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Berthold Pemp, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00880139     History of Changes
Other Study ID Numbers: OPHT-171008
Study First Received: December 18, 2008
Last Updated: November 30, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Diabetes mellitus, type 1
Inflammation
Cytokines
Vascular reactivity

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetic Retinopathy
Inflammation
Retinal Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014