UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036520 |
|---|---|
| Receipt number | R000041609 |
| Scientific Title | Impact of whole body vibration on glucose metabolism in healthy men |
| Date of disclosure of the study information | 2019/06/12 |
| Last modified on | 2020/09/14 10:20:56 |
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Basic information
Public title
Impact of whole body vibration on glucose metabolism in healthy men
Acronym
Impact of whole body vibration on glucose metabolism in healthy men
Scientific Title
Impact of whole body vibration on glucose metabolism in healthy men
Scientific Title:Acronym
Impact of whole body vibration on glucose metabolism in healthy men
Region
| Japan |
Condition
Condition
healthy men
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the influence of whole body vibration exercise before and after oral glucose load on glucose metabolism
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma glucose levels
Key secondary outcomes
Blood insulin, glucagon, growth hormone, cortisol, cathecolamines, and adiponectin levels and pulse
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1. 75-g oral glucose tolerance test (OGTT),
2. WBV exercise after 75-g OGTT,
3. WBV exercise before 75-g OGTT
Interventions/Control_2
1. 75-g OGTT,
2. WBV exercise before 75-g OGTT,
3. WBV exercise after 75-g OGTT
Interventions/Control_3
1. WBV exercise after 75-g OGTT,
2. 75-g OGTT,
3. WBV exercise before 75-g OGTT
Interventions/Control_4
1. WBV exercise after 75-g OGTT,
2. WBV exercise before 75-g OGTT,
3. 75-g OGTT
Interventions/Control_5
1. WBV exercise before 75-g OGTT
2. 75-g OGTT,
3. WBV exercise after 75-g OGTT,
Interventions/Control_6
1. WBV exercise before 75-g OGTT
2. WBV exercise after 75-g OGTT,
3. 75-g OGTT,
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy men
Key exclusion criteria
1. subjects who have been diagnosed as diabetes or glucose intolerance
2. subjects who have diseases potentially associated with glucose intolerance
3. subjects who have diseases whose symptoms will be potentially deteriorated by vibration (dizziness etc.)
4. subjects who have a risk of fall
5. subjccts who cannnot give informed consent
6. subjects whom researchers judge to be inappropriate
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Mitsuyoshi |
| Middle name | |
| Last name | Takahara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Diabetes Care Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3732
takahara@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita City, Osaka
TEL
06-6879-3732
Homepage URL
h.watanabe.med@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
2-2 Yamadaoka, Suita City, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2019 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 15 | Day |
Last modified on
| 2020 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041609
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
