UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001336 |
|---|---|
| Receipt number | 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 16:03:22 |
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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
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
t-kondo@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001624
