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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name