UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049432 |
|---|---|
| Receipt number | R000056284 |
| Scientific Title | Efficacy of exercise under hypoxia for insulin sensitivity, and prevention of sarcopenia |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2023/05/17 11:52:19 |
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Basic information
Public title
Efficacy of exercise under hypoxia for insulin sensitivity, and prevention of sarcopenia
Acronym
Efficacy of exercise under hypoxia for insulin sensitivity, and prevention of sarcopenia
Scientific Title
Efficacy of exercise under hypoxia for insulin sensitivity, and prevention of sarcopenia
Scientific Title:Acronym
Efficacy of exercise under hypoxia for insulin sensitivity, and prevention of sarcopenia
Region
| Japan |
Condition
Condition
Healthy subject without diabetes
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have investigated the safety for exercise under hypoxia on healthy subjects. But the efficacy for exercise under hypoxia is still not clear.
We hypothesize exercise under hypoxia improve insulin sensitivity and increase skeletal muscle mass on healthy subjects. We will investigate the efficacy for exercise under hypoxia on healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
insulin sensitivity, skeletal muscle mass
Key secondary outcomes
vital capacity
weight loss
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
sedentary
Interventions/Control_2
exercise under normal oxygen (30min 3 times per week)
Interventions/Control_3
exercise under hypoxia (16% O2 30min 3 times per week)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects without diabetes
whose age is above 20yo under 60yo
who can do exercise for 30min
who are not pregnant
who don't have arrythmia and heart disease
who have unstable disease
Key exclusion criteria
whose criteria is conflict with key inclusion criteria
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Araki |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
Chuo-ku Honjyo 1-1-1 Kumamoto city, Kumamoto Prefecture
TEL
0963737380
fukudakazuki@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fukuda |
Organization
Kumamoto University
Division name
Center for metabolic regulation of healthy aging
Zip code
8608556
Address
Chuo-ku Honjyo 1-1-1 Kumamoto city, Kumamoto Prefecture
TEL
0963737380
Homepage URL
fukudakazuki@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Manpei Suzuki Diabetes Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital Institutional Review Board
Address
Chuo-ku Honjyo 1-1-1 Kumamoto city, Kumamoto Prefecture
Tel
0903737380
fukudakazuki@kumamoto-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
| 2023 | Year | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056284
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
