UMIN-CTR Clinical Trial

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
Email	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
Email	h.watanabe.med@endmet.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041609