VasodilationVMDNCT05492071
Impact of Regional Vibration Application and Flow Mediated Dilation on Brachial Artery Hemodynamics
A study testing Local Vibration Application Following Flow Mediated Dilation and Flow mediated dilation in people with Vasodilation and Diabetes Mellitus, Type 2, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasodilation, Diabetes Mellitus, Type 2
- What is being tested?
- Local Vibration Application Following Flow Mediated Dilation and Flow mediated dilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Aug 2022to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 80
- Sinus Rhythm in ECG
- Ejection Fraction > %35
- Informed Consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department of Cardiology
Istanbul, 34290
About this study
Official title: Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
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.
Read the 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:
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.
- Conditions
- Vasodilation, Diabetes Mellitus, Type 2
- Being tested
- Local Vibration Application Following Flow Mediated Dilation, Flow mediated dilation
- Keywords
- Vibration, Peripheral Artery Hemodynamics, Diabetes Mellitus
- Medical subject headings
- Aneurysm, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Vibration Application Following Flow Mediated DilationDevice
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.
Flow mediated dilationOther
Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure).
| Study group | Role | What they receive |
|---|---|---|
| Local Vibration Application Following Flow-Mediated Dilation Application | Experimental | 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. Receives: Device: Local Vibration Application Following Flow Mediated Dilation |
| Flow-Mediated Dilation Application | Experimental | Flow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). Receives: Other: Flow mediated dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial Artery Diameter
vessel diameter in millimeters
Measured: Up to 10 minutes after vibration application initiation
Brachial Artery Mean Flow Velocity
Mean flow velocity ( cm/sec) measured with Doppler
Measured: Up to 10 minutes after vibration application initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start8 Aug 2022
- Primary completion10 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for VasodilationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Murat Sezer, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492071
- Sponsor's protocol ID
- 2020/755
- Acronym
- VMD
- Status last verified
- Feb 2023
- First submitted
- 4 Aug 2022
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21042329Robbins 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.
PubMed 24237890Aoyama 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.
PubMed 31257335
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System
- ClinicalTrials.gov ID
- NCT05492071
- Acronym / sponsor ID
- VMD / 2020/755
- Conditions
- Vasodilation, Diabetes Mellitus, Type 2
- Keywords
- Vibration, Peripheral Artery Hemodynamics, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Vibration Application Following Flow-Mediated Dilation Application | Experimental | Device: Local Vibration Application Following Flow Mediated DilationFlow 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. |
| Flow-Mediated Dilation Application | Experimental | Other: Flow mediated dilationFlow mediated dilatation will be induced via 5 min cuff inflation below left elbow at suprasystolic pressures (50mmHg above preapplication systolic pressure). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 80
- Sinus Rhythm in ECG
- Ejection Fraction > %35
- Informed Consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Vibration Application Following Flow Mediated DilationFlow 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 Application |
| Flow mediated dilationFlow 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 Application |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 21042329Herrero 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.
- Background: PubMed 24237890Robbins 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.
- Background: PubMed 31257335Aoyama 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.
Related trials for Vasodilation
Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
Endothelial Function
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingEarly Phase 1
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
Aging, Menopause
RecruitingPhase 2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Frailty, Mild Cognitive Impairment
RecruitingEarly Phase 1
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Obesity, Vasodilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Vibration Application Following Flow Mediated Dilation and Flow mediated dilation in people with Vasodilation and Diabetes Mellitus, Type 2, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial Artery Diameter (time frame: Up to 10 minutes after vibration application initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05492071, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.