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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771835
First received: October 24, 2012
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Retinal Venous Pressure and Endothelin-1 in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Quantification of retinal venous pressure (RVP) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quantification of ET-1 in correlation with RVP [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes patients
Patients with diabetes mellitus type I + II, without diabetic retinopathy

Detailed 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.

  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

Patients with diabets mellitus type I or II, without diabetic retinopathy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771835

Locations
Switzerland
University of Basel, Dept. of Ophthalmology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Josef Flammer, MD University of Basel, Dept. of Ophthalmology
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771835     History of Changes
Other Study ID Numbers: 089-CYA-2012
Study First Received: October 24, 2012
Last Updated: January 16, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
diabetes mellitus
retinal venous pressure
endothelin-1

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014