UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016319 |
|---|---|
| Receipt number | R000018005 |
| Scientific Title | Intervention using Electrical Muscle Stimulation in type 2 diabetes |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2016/02/02 17:01:14 |
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Basic information
Public title
Intervention using Electrical Muscle Stimulation in type 2 diabetes
Acronym
intervention using electrical muscle stimulation in type 2 diabetes
Scientific Title
Intervention using Electrical Muscle Stimulation in type 2 diabetes
Scientific Title:Acronym
intervention using electrical muscle stimulation in type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
examination of the effect of electrical muscle stimulation on glucose control in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
glucose, HbA1c, HOMA-IR, TG, LDL-C
Key secondary outcomes
weight, body fat
Base
Study type
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
electrical muscle stimulation
Interventions/Control_2
control
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
patients can exercise
Key exclusion criteria
dementia
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Miyamoto |
Organization
Hyogo University of Health Sciences
Division name
Faculty of Rehabilitation,
Zip code
Address
1-3-6 Minatojima, Chuo-ku, Kobe
TEL
078-304-3073
t-miyamoto@huhs.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Miyamoto |
Organization
Hyogo University of Health Sciences
Division name
Faculty of Rehabilitation,
Zip code
Address
1-3-6 Minatojima, Chuo-ku, Kobe
TEL
078-304-3073
Homepage URL
t-miyamoto@huhs.ac.jp
Sponsor or person
Institute
Hyogo University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from Japan Society for the Promotion of Science (
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸市立医療センター中央市民病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 23 | 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
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018005
| Research Plan | |
|---|---|
| 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 |
