UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016309 |
|---|---|
| Receipt number | R000018931 |
| Scientific Title | Amelioration of glucose homeostasis and visceral adiposity in obese type 2 diabetes by mild electrical stimulation with heat shock (MES+HS) therapy |
| Date of disclosure of the study information | 2015/01/23 |
| Last modified on | 2016/01/23 18:11:11 |
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Basic information
Public title
Amelioration of glucose homeostasis and visceral adiposity in obese type 2 diabetes by mild electrical stimulation with heat shock (MES+HS) therapy
Acronym
Clinical effects of MES+HS in diabetes
Scientific Title
Amelioration of glucose homeostasis and visceral adiposity in obese type 2 diabetes by mild electrical stimulation with heat shock (MES+HS) therapy
Scientific Title:Acronym
Clinical effects of MES+HS in diabetes
Region
| Japan |
Condition
Condition
Obese type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of MES+HS on glucose homeostasis and visceral adiposity in obese T2DM, especially
1) if there is gender difference
2) which is the most effective (twice, 4 times or 7 times a week)
3) concomitant medications such as DPP-4 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Visceral adipose volume
2) HbA1c
Key secondary outcomes
1) chronic inflammatory markers
2) hepatic steatosis marker
3) renal function
4) lipid metabolism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
MES+HS treatment twice a week without DPP-4 inhibitor for 12 weeks
Interventions/Control_2
MES+HS treatment 4 times a week without DPP-4 inhibitor for 12 weeks
Interventions/Control_3
MES+HS treatment 7 times a week without DPP-4 inhibitor for 12 weeks
Interventions/Control_4
MES+HS treatment twice a week with DPP-4 inhibitor for 12 weeks
Interventions/Control_5
MES+HS treatment 4 times a week with DPP-4 inhibitor for 12 weeks
Interventions/Control_6
MES+HS treatment 7 times a week with DPP-4 inhibitor for 12 weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Waist circumference:
Male: more than 85 cm
Female: more than 90 cm
2) HbA1c (NGSP): from 7.0% to less than 9.4%
3) Treated with or without DPP-4 inhibitors
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
60
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
1-1-1Honjo, Chuo-Ward, 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
1-1-1Honjo, Chuo-Ward, 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
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
熊本大学医学部附属病院（熊本県）、荒尾市民病院（熊本県）、公立玉名中央病院（熊本県）、菊池郡市医師会立病院（熊本県）、健康保険熊本総合病院（熊本県）、国保水俣市立総合医療センター（熊本県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018931
