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NCT01771835 Clinical Trial

Retinal Venous Pressure and ET-1 in Patients With Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01771835
Other study ID # 089-CYA-2012
Secondary ID
Status Completed
Phase N/A
First received October 24, 2012
Last updated January 16, 2013
Start date August 2011
Est. completion date November 2012

Study information
Verified date January 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

Measurement of the circulation in patients with diabetes mellitus and establish a link between retinal venous pressure (RVP) and endothelin (ET-1)levels.

Description:

Diabetic retinopathy and maculopathy are the main causes of visual loss. Hyperglycemia as the main risk factor of diabetic retinopathy induced damage to retinal capillaries. These in turn lead to hypoxia in the tissue and promote the release of VEGF (vascular endothelial growth factor) , which in turn increases the vascular pathology. Simultaneously, there is an increased expression of endothelin (ET-1). Endothelin increases vascular tone and regulates the micro-and macro-vascular remodeling.

In ocular blood flow perfusion pressure plays an important role. While in healthy eyes a spontaneous retinal venous pulsation is frequently observed, this is significantly less frequent in diseased eyes. An increased venous pressure lowers the ocular perfusion pressure, and increases the transmural pressure. A measurement of the retinal venous pressure and the hormone ET-1 in the blood will give us a better knowledge of the circulatory changes and their relationship to diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- diabetes mellitus type I or II

- no diabetic retinopathy

Exclusion Criteria:

- known diabetic retinopathy

- acute or chronic inflammation of the eyes

- narrow angle glaucoma

- minority

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University of Basel, Dept. of Ophthalmology Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quantification of retinal venous pressure (RVP) 30 minutes No
Secondary Quantification of ET-1 in correlation with RVP 30 minutes No
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