UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042787 |
|---|---|
| Receipt number | R000048831 |
| Scientific Title | The effect of vibration-induced muscle tone suppression on myokine and glucose metabolism |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2020/12/18 14:08:22 |
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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
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
mjmj0816@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048831
