UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003210 |
|---|---|
| Receipt number | R000003892 |
| Scientific Title | Amelioration of glucose homeostasis and visceral adiposity in type 2 diabetes by mild electrical current and thermo therapy |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2015/02/19 14:01:36 |
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Basic information
Public title
Amelioration of glucose homeostasis and visceral adiposity in type 2 diabetes by mild electrical current and thermo therapy
Acronym
Metabolic ameliorations in T2DM by MET
Scientific Title
Amelioration of glucose homeostasis and visceral adiposity in type 2 diabetes by mild electrical current and thermo therapy
Scientific Title:Acronym
Metabolic ameliorations in T2DM by MET
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of MET on glucose homeostasis and visceral adiposity in T2DM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of biomarkers related to T2DM at 12 weeks and 24 weeks after MET treatment.
Key secondary outcomes
General assessment of MET device evaluated by subjects.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
12 weeks of MET (4 times a week, 60 min each time), and then 12 weeks of withdrawal, 20 subjects.
Interventions/Control_2
12 weeks of no treatment, and then 12 weeks of MET (4 times a week, 60 min each time), 20 subjects.
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
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
T2DM patients having waist circumference greater than 85 cm with HbA1c, greater than or equal 6.5%, and less than 9.0%.
Key exclusion criteria
i) Past history or current medication of myocardial infarction, angina, apoplexy and arteriosclerosis obliterans.
ii)Severe wound, infections, pre- or post-operation.
iii)Severe liver dysfunction (GOT and/or GPT: greater than 100U).
iv)Chronic heart failure, familial dyslipidemia.
v)Severe diabetic complications.
vi)Pacemaker carrier.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Araki |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
096-373-5169
earaki@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Kondo |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Metabolic Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto, Japan
TEL
096-373-5169
Homepage URL
t-kondo@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine,
Faculty of Life Sciences,
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine,
Faculty of Life Sciences,
Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto University Hospital
Yatsuda Hospital
Yamasaki Clinic
Konno Hospital
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
熊本大学大学医学部附属病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ebiomedicine.com/article/S2352-3964(14)00025-5/abstract
Number of participants that the trial has enrolled
Results
Reduction of visceral adiposity,
improvement in glucose intolerance and insulin resistance
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 | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 19 | Day |
Last modified on
| 2015 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003892
