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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001336
Receipt No. R000001624
Scientific Title The efficacy and safety of Mild Electric current and Thermo (MET) in healthy human subjects.
Date of disclosure of the study information 2008/08/26
Last modified on 2008/12/12

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Basic information
Public title The efficacy and safety of Mild Electric current and Thermo (MET) in healthy human subjects.
Acronym The efficacy and safety of MET in healthy human subjects.
Scientific Title The efficacy and safety of Mild Electric current and Thermo (MET) in healthy human subjects.
Scientific Title:Acronym The efficacy and safety of MET in healthy human subjects.
Region
Japan

Condition
Condition healthy males
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the effects of MET on visceral adiposity and glucose metabolism, and safety in healthy male subjects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Waist circumference, visceral adipose tissue volume, subcutaneous fat tissue volume, several parameters on glucose metabolism
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ten healthy male subjects were treated with MET (12V, 55 pulses per second, 30 min at 42 degrees) twice a week for 8 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
25 years-old <=
Age-upper limit
40 years-old >=
Gender Male
Key inclusion criteria apparent healthy
Key exclusion criteria Diabetes, Metabolic syndrome, Hypertension, Dyslipidemia, Atherosclerosis
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kondo
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto
TEL 096-373-5169
Homepage URL
Email t-kondo@gpo.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Department of Metabolic Medicine, Graduate School of Medical Sciences, Kumamoto University,
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 26 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
2006 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2007 Year 02 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 26 Day
Last modified on
2008 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001624

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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