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Clinical Trials/NCT05492071
NCT05492071CompletedNot Applicable

Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Istanbul University2 sites in 1 country80 target enrollmentStarted: August 8, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
2
Primary Endpoint
Brachial Artery Diameter

Study Overview

Brief Summary

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:

  1. 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.
  2. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.

Detailed Description

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Brachial Artery Diameter

Time Frame: Up to 10 minutes after vibration application initiation

vessel diameter in millimeters

Brachial Artery Mean Flow Velocity

Time Frame: Up to 10 minutes after vibration application initiation

Mean flow velocity ( cm/sec) measured with Doppler

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Murat Sezer

Professor, MD

Istanbul University

Study Sites (2)

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