Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers.

Hypertension Clinical Trial

Official title:

Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432029
• Other study ID #: OPHT-180506
• Status: Completed
• Phase: N/A
• First received: February 5, 2007
• Last updated: July 1, 2008
• Start date: December 2006
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. We have recently used this visual stimulation technique as a new and powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we could show that this response is diminished in patients with vascular pathologies and that the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may reflect endothelial dysfunction and may be a new approach to test endothelial function in vivo.

One of the most widely used method for the assessment of endothelial function is flow mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular function in vivo. In the present study, we set out to compare the standard method for the evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with diabetic retinopathy:

• Men and women aged > 18 years.

• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant.

• Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative diabetic retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Level of diabetic retinopathy will be assessed according to the criteria defined in the AREDS-study.(1991)

• serum cholesterol < 250 mg/dl (treated or untreated)

Patients with mild hypertension and/or hypercholesterinemia:

• Men and women aged > 18 years.

• mild essential hypertension defined as a blood pressure meeting the criterion of hypertension grade 1 of the World Health Organisation blood pressure classification

• systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg and/or

• serum cholesterol > 250 mg/dl

• blood pressure will be measured at two different occasion in a sitting positions

Healthy subjects:

• Men and women aged > 18 years.

• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

• normal ocular findings

• serum cholesterol < 200 mg/dl

• systolic blood pressure between 110mmHg and 140mmHg

• diastolic blood pressure < 90 mmHg

Exclusion Criteria:

• Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Blood donation during the previous 3 weeks

• other ocular pathologies than diabetic retinopathy level 1 or 2

• History or family history of epilepsy

• Ametropy greater or equal than 3 dpt

• systolic blood pressure < 100mmHg

• diastolic blood pressure < 75mmHg

• pregnant or lactating women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypercholesterolemia
• Hypertension
• Regional Blood Flow

Intervention

Procedure:
• Forearm blood flow measurement, Flow mediated dilation (FMD)
Forearm blood flow measurement: baseline 1 min, 3 min after inflation of cuff, 4 min after 0.8mg Nitroglycerin

Device:
• Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light
Stimulation with Flicker-light: 1 min, measurement without flickering light 4 min after 0.8 mg Nitroglycerin

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vessel diameters (Retinal vessel analyzer)		8 min	No
Primary	Forearm Blood Flow		8 min	No