UMIN-CTR Clinical Trial

Basic information
Public title	The effect of vibration-induced muscle tone suppression on myokine and glucose metabolism
Acronym	The effect of vibration-induced muscle tone suppression on myokine and glucose metabolism
Scientific Title	The effect of vibration-induced muscle tone suppression on myokine and glucose metabolism
Scientific Title:Acronym	The effect of vibration-induced muscle tone suppression on myokine and glucose metabolism
Region	Japan

Condition
Condition	Obese subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of vibration-induced muscle tone suppression on myokine and glucose metabolism
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Glycometabolism 2. Muscle hardness 3. Biomarkers
Key secondary outcomes	1. Body compositions (height, weight, muscle mass, fat mass, bone mass) 2. Daily physical activity level 3. Liver hardness 4. Fatigue and subjective symptoms 5. Health literacy 6. Physical exercise consciousness

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	The subject is stimulated by a whole-body vibration for 30 minutes.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Adults aged 40-74 years and with BMI over25 kg/m2 2.Applicants with at least 1 risk factor of metabolic syndrome 3.Applicants who can join all measurements and participate in the vibration program both in the fitness room and at home during the one-month experiment.
Key exclusion criteria	1.Applicants who are taking neuropsychiatric drugs 2.Applicants suffering from serious diseases such as brain dysfunction, renal disease, heart disease, peripheral angiopathy, etc 3.Applicants with excessive intake of alcohol every day 4.Applicants who are joining other clinical experiments or having participated in any other clinical experiments in the past 3 months 5.Applicants who are pregnant or likely to be pregnant 6.Applicants judged as inappropriate participants by the principal researcher
Target sample size	20

Research contact person
Name of lead principal investigator	1st name SECHANG Middle name Last name OH
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code	3058575
Address	Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575
TEL	0298533218
Email	ohsechang@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Mijin Middle name Last name Kim
Organization	University of Tsukuba
Division name	Industry-University Collaborative R&D Center for Tailor-Made QOL
Zip code	305-8550
Address	Innovation Medical Research Institute, Laboratory No. 407 1-2 Kasuga, Tsukuba, Ibaraki
TEL	0298592733
Homepage URL
Email	mjmj0816@gmail.com

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Tsukuba
Address	1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
Tel	0298532571
Email	hitorinri@un.tsukuba.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 01 Month 04 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2020 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048831