Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
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ClinicalTrials.gov Identifier: NCT00880139 |
Recruitment Status
:
Terminated
First Posted
: April 13, 2009
Last Update Posted
: November 14, 2014
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Tracking Information | ||||
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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 |
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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 |
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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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | outpatients | |||
Condition |
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Intervention |
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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. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment |
33 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Medical University of Vienna | |||
Verification Date | November 2014 |