UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002723 |
|---|---|
| Receipt number | R000003316 |
| Scientific Title | The acute effect of electrical muscle stimulation on glucose metabolism in type2 diabetes |
| Date of disclosure of the study information | 2009/11/06 |
| Last modified on | 2009/11/06 21:28:05 |
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Basic information
Public title
The acute effect of electrical muscle stimulation on glucose metabolism in type2 diabetes
Acronym
effect of elactrical stimulation on glucose metabolism in type2 diabetes
Scientific Title
The acute effect of electrical muscle stimulation on glucose metabolism in type2 diabetes
Scientific Title:Acronym
effect of elactrical stimulation on glucose metabolism in type2 diabetes
Region
| Japan |
Condition
Condition
patients with type2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether electrical muscle stimulation lessens postprandial hyperglycemia in type2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial glucose concentration
Key secondary outcomes
insulin
C peptide
creatine phosphokinase
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In intervention trial, patients are performed 30min electrical muscle stimulation 30minutes after meal
Interventions/Control_2
In control trial, patients keep rest
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
Key inclusion criteria
type2 diabetes
Key exclusion criteria
patients with treatment by insulin therapy
and/or
patients cannot exercise because of various complications(ie. cardiovascular disease,diabetic complications)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Moritani |
Organization
Graduate school of Human and Environmental studies, Kyoto University
Division name
labolatory of applied physiology
Zip code
Address
Nihonmatsu-cho, Yoshida, Sakyo-ku, Kyoto, Japan
TEL
075-753-2878
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Miyamoto |
Organization
Graduate school of Human and Environmental studies, Kyoto University
Division name
labolatory of applied phisiology
Zip code
Address
Nihonmatsu-cho, Yoshida, Sakyo-ku, Kyoto, Japan
TEL
075-753-2878
Homepage URL
m.toshiaki@ax8.ecs.kuoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
京都逓信病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 06 | 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
| 2009 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 06 | Day |
Last modified on
| 2009 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003316
