Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics

Study Overview
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Brief Summary
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Application of vibration has been previously shown to affect tissue perfusion and utilized in different branches of medicine. Little is known about the acute impact of vibration application on peripheral artery hemodynamics. In this study, investigators intend to assess: vibration induced hemodynamic changes in brachial artery in non-diabetic patients and compare the characteristics of these alterations with flow mediated dilation mediated changes in same cohort. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.

Detailed Description
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Background and Rationale: Vibration application has been previously shown to affect tissue perfusion and utilized in different branches of medicine. However, previous studies have mainly focused on the impact of vibration on skin perfusion or vibration with active muscle contractions, therefore couldn't truly demonstrate acute impact of local vibration application on peripheral arteries. In addition to that, as a population that is prone to develop vascular problems, it is not known whether diabetic patients have comparable response to vibration application with non-diabetic population. Objectives: In this study, investigators aim to demonstrate and compare hemodynamic alterations in brachial artery with paired measurements pre- and post- vibration application and compare the characteristics of these changes with those of flow-mediated dilation in a non-diabetic cohort. Additionally, differences and similarities in vascular hemodynamic response to vibration in diabetic and non-diabetic subgroups are intended to be elucidated. Methods: Flow mediated dilatation and vibration will be applied after the participants will abstain from alcohol, caffeine and nicotine for 24 hours. Flow mediated dilatation (FMD) will be induced via 5 min cuff inflation below left elbow at supra-systolic pressures (50mmHg above pre-application systolic pressure). Vibration will be applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD. Left Brachial artery flow will be measured with pulsed Doppler and diameter will be measured via 2D ultrasonographic imaging at 0th, 2nd, 4th, 6th, 8th minutes.Throughout the entire application and measurement periods, patients will be continuously monitored with electrocardiogram.

Official Title
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Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Conditions
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Vasodilation, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Local Vibration Application Following Flow Mediated Dilation
* Other: Flow mediated dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 80 Sinus Rhythm in ECG Ejection Fraction > %35 Informed Consent Exclusion Criteria: Unstabile angina Certain or suspected subclavian artery or brachial artery atherosclerotic disease (assessed with USG) Heart failure ( New York Heart Association III - IV) Atrial fibrillation or frequent extrasystoles in ECG.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local Vibration Application Following Flow-Mediated Dilation Application<br>Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). Vibration is applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD. | Device: Local Vibration Application Following Flow Mediated Dilation<br>* Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). Vibration is applied with a commercially available vibration plate to forearm at 20 hz and 3 mm of vertical amplitude for 5 minutes, 30 minutes after termination of FMD.<br>|
| Experimental: Flow-Mediated Dilation Application<br>Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). | Other: Flow mediated dilation<br>* Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brachial Artery Diameter | vessel diameter in millimeters | Up to 10 minutes after vibration application initiation | 
| Brachial Artery Mean Flow Velocity | Mean flow velocity ( cm/sec) measured with Doppler | Up to 10 minutes after vibration application initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibration, Peripheral Artery Hemodynamics, Diabetes Mellitus