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

Tracking Information
First Submitted Date	December 18, 2008
First Posted Date	April 13, 2009
Last Update Posted Date	November 14, 2014
Study Start Date	June 2009
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 10, 2009)	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 ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT00880139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 10, 2009)	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 ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
Official Title	A Cross-sectional Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	outpatients
Condition	Diabetic Retinopathy; Inflammation
Intervention	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
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Terminated
Actual Enrollment; (submitted: November 13, 2014)	33
Original Estimated Enrollment; (submitted: April 10, 2009)	50
Actual Study Completion Date	September 2012
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Austria
Removed Location Countries
Administrative Information
NCT Number	NCT00880139
Other Study ID Numbers	OPHT-171008
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Gerhard Garhofer, Medical University of Vienna
Study Sponsor	Medical University of Vienna
Collaborators	Not Provided
Investigators	Principal Investigator: Berthold Pemp, MD Department of Clinical Pharmacology, Medical University of Vienna
PRS Account	Medical University of Vienna
Verification Date	November 2014