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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002723
Receipt No. 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

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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
Email

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
Email m.toshiaki@ax8.ecs.kuoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003316

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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