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
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
- Blue field stimulator
- BFS-2050
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:
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
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 May 23, 2013