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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT00432029
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 3
• Duration (Months): 13
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1; Hypertension; Hypercholesterolemia; Regional Blood Flow	Procedure: Forearm blood flow measurement, Flow mediated dilation (FMD); Device: Zeiss Retinal Vessel Analyzer (RVA), Stimulation with Flicker-light	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 IDDM	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
Other: 2 Hypercholesterolemia and/or Hypertension	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
Other: 3 age/sex matched healthy control subjects	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

Outcome Measures

Primary Outcome Measures

1. Retinal vessel diameters (Retinal vessel analyzer) [8 min]

2. Forearm Blood Flow [8 min]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology, Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

• Medical University of Vienna

Investigators

• Principal Investigator: Michael Wolzt, MD, Department of Clinical Pharmacology, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00432029
• Other Study ID Numbers: OPHT-180506
• First Posted: Feb 6, 2007
• Last Update Posted: Jul 4, 2008
• Last Verified: Jun 1, 2008

• Keywords provided by , ,: Flicker induced vasodilatation; Flow mediated vasodilatation; Forearm blood flow; Retinal vessel diameter; Endothelial dysfunction
• Additional relevant MeSH terms: Hypercholesterolemia; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jul 4, 2008