UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038658 |
|---|---|
| Receipt number | R000043920 |
| Scientific Title | Effects of Work out on Glucose Homeostasis |
| Date of disclosure of the study information | 2020/01/10 |
| Last modified on | 2019/11/11 14:27:04 |
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Basic information
Public title
Effects of Work out on Glucose Homeostasis
Acronym
WORKG-pilot
Scientific Title
Effects of Work out on Glucose Homeostasis
Scientific Title:Acronym
WORKG-pilot
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effects of work out on glucose homeostasis and blood levels of glucose and other markers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of muscle volume and blood glucose control
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Work out for 24 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who have been diagnosed as type 2 diabetes and continue their therapies adequately, in addition, who are able to join a 24 week course, twice per week, at a work out gym, and 3 exams in a health check lab in Tokyo.
Key exclusion criteria
Diabetic patients with nephrological disorder grade 3 or more, retinopathy grade A2 or worse, having neuropathy, or having experience of stroke or heart attack within 6 month. Individuals who are considered not to participate in this study will be also excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masumi |
| Middle name | |
| Last name | Ai |
Organization
Tokyo Medical and Dental University
Division name
Department of Insured Medical Care Management
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0338136111
ai.vasc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Masumi |
| Middle name | |
| Last name | Ai |
Organization
Tokyo Medical and Dental University
Division name
Department of Insured Medical Care Management
Zip code
1138519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
0338136111
Homepage URL
ai.vasc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
RIZAP Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Medical school, Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
0338136111
info.bec@tmd.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
| 2020 | Year | 01 | Month | 10 | 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
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043920
