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

NCT ID: NCT01771835

Last Updated: 2013-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes patients

Patients with diabetes mellitus type I + II, without diabetic retinopathy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josef Flammer, MD

Role: STUDY_DIRECTOR

University of Basel, Dept. of Ophthalmology

Locations

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University of Basel, Dept. of Ophthalmology

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Cybulska-Heinrich AK, Baertschi M, Loesche CC, Schoetzau A, Konieczka K, Josifova T, Flammer J. Patients with diabetic retinopathy have high retinal venous pressure. EPMA J. 2015 Feb 24;6(1):5. doi: 10.1186/s13167-015-0027-1. eCollection 2015.

Reference Type DERIVED
PMID: 25793018 (View on PubMed)

Other Identifiers

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089-CYA-2012

Identifier Type: -

Identifier Source: org_study_id

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