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

NCT00880139 | Terminated

• 1 other identifier: OPHT-171008
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Inflammation

Keywords

Diabetes mellitus, type 1; Inflammation; Cytokines; Vascular reactivity

Outcome Measures

Primary Outcomes (4)

• Plasma biomarkers for inflammation (CRP, TNF-α, IL-6, vWF, e-Selektin)

  1 day

• Perifoveal white cell blood flow (Blue field entoptic technique)

  1 day

• Retinal vessel reactivity to flicker stimulation (Retinal Vessel Analyzer)

  1 day

• Arteriolar to venous ratio

  1 day

Secondary Outcomes (5)

• Capillary blood glucose

  1 day

• Stage of diabetic retinopathy

  1 day

• Visual acuity

  1 day

• Intraocular pressure

  1 day

• Systolic/diastolic arterial blood pressure, pulse rate

  1 day

Interventions

Blood sampling PROCEDURE

Determination of cytokine plasma levels (ELISA)

Noninvasive measurement of systemic hemodynamics PROCEDURE

performed once

Visual acuity assessment PROCEDURE

ETDRS charts

Blue field entoptic technique (Blue field stimulator, BFS-2050) DEVICE

performed once

Also known as: Blue field stimulator, BFS-2050

Ophthalmic examination and fundus photography PROCEDURE

7 + 1 standard fields

Retinal Vessel Analyzer (DVA) DEVICE

Assessment of retinal vessel reactivity to stimulation with flickering light

Also known as: DVA

High resolution optical coherence tomography (OCT) DEVICE

performed once

Also known as: OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Inflammation; Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Berthold Pemp, MD

  Department of Clinical Pharmacology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. - Doz. Dr

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: April 13, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

AU (1)