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

Diabetes Mellitus, Type 2 Clinical Trial

— VMD  

Official title:

Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492071
• Other study ID #: 2020/755
• Status: Completed
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: February 2023
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 20, 2022
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Vasodilation

Intervention

Device:
• Local Vibration Application Following Flow Mediated Dilation
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.

Other:
• Flow mediated dilation
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Aoyama A, Yamaoka-Tojo M, Obara S, Shimizu E, Fujiyoshi K, Noda C, Matsunaga A, Ako J. Acute Effects of Whole-Body Vibration Training on Endothelial Function and Cardiovascular Response in Elderly Patients with Cardiovascular Disease. Int Heart J. 2019 Jul 27;60(4):854-861. doi: 10.1536/ihj.18-592. Epub 2019 Jun 28. — View Citation

Herrero AJ, Menendez H, Gil L, Martin J, Martin T, Garcia-Lopez D, Gil-Agudo A, Marin PJ. Effects of whole-body vibration on blood flow and neuromuscular activity in spinal cord injury. Spinal Cord. 2011 Apr;49(4):554-9. doi: 10.1038/sc.2010.151. Epub 2010 Nov 2. — View Citation

Robbins D, Yoganathan P, Goss-Sampson M. The influence of whole body vibration on the central and peripheral cardiovascular system. Clin Physiol Funct Imaging. 2014 Sep;34(5):364-9. doi: 10.1111/cpf.12103. Epub 2013 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Magnitude of Maximum Blood Flow Change	Magnitude of Maximum Blood Flow Change in Diabetic and Nondiabetic subgroups	Up to 10 minutes after vibration application initiation
Other	Magnitude of Maximum Diameter Change	Magnitude of Maximum Diameter Change in Diabetic and Nondiabetic subgroups	Up to 10 minutes after vibration application initiation
Other	Magnitude of Maximum Resistance Change	Magnitude of Maximum Resistance Change in Diabetic and Nondiabetic subgroups	Up to 10 minutes after vibration application initiation
Other	Magnitude of Maximum Mean Flow Velocity Change	Magnitude of Maximum Mean Flow Velocity Change in Diabetic and Nondiabetic subgroups	Up to 10 minutes after vibration application initiation
Primary	Brachial Artery Diameter	vessel diameter in millimeters	Up to 10 minutes after vibration application initiation
Primary	Brachial Artery Mean Flow Velocity	Mean flow velocity ( cm/sec) measured with Doppler	Up to 10 minutes after vibration application initiation