UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007792
Receipt number R000009184
Scientific Title The analysis of monocyte characters on Mild Electrical stimulation with hyperThermia treatment in metabolic syndrome or type 2 diabetes.
Date of disclosure of the study information 2012/04/20
Last modified on 2015/04/20 09:20:06

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Basic information

Public title

The analysis of monocyte characters on Mild Electrical stimulation with hyperThermia treatment in metabolic syndrome or type 2 diabetes.

Acronym

The analysis of monocyte characters on MET treatment in MS or T2DM

Scientific Title

The analysis of monocyte characters on Mild Electrical stimulation with hyperThermia treatment in metabolic syndrome or type 2 diabetes.

Scientific Title:Acronym

The analysis of monocyte characters on MET treatment in MS or T2DM

Region

Japan


Condition

Condition

Metabolic syndrome
Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Mild Electrical stimulation with hyperThermia (MET) improves insulin resistance and glucose homeostasis.
This study aims to identify the molecular mechanisms to improve metabolic profiles on MET, especially in circulating monocytes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The expression of CRP, IL-6, NF-kB, TNF-a, HSP72 in monocytes.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

MET treatment (1.4 V/cm, 0.1ms, 55 pps, 42 degrees for 60min), 4 times/week for 4weeks. Then 4weeks of no treatment.

Interventions/Control_2

First, 4 weeks of no treatment. Then, MET treatment (1.4 V/cm, 0.1ms, 55 pps, 42 degrees for 60min), 4 times/week for 4weeks.

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

65 years-old >=

Gender

Male

Key inclusion criteria

Metabolic syndrome (MS)
Abdominal obesity, given as waist circumference
greater than 85 cm with meets 2 criteria in 3 shown below,
i)Triglycerides: greater than or equal to 150 mg/dL and/or HDL cholesterol: less than 40 mg/dL
ii)Systolic Blood pressure: greater than or equal to130 mmHg and/or Diastolic blood pressure: greater than or equal to 85 mmHg
iii)Fasting blood glucose: greater than or equal to 110 mg/dL

Type 2 diabetes mellitus (T2DM)
i)Abdominal obesity, given as waist circumference
greater than 85 cm
ii)HbA1c more than 6.9%, less than 9.5% (NGSP)

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)HbA1c : greater than or equal to 6.9%. (only in MS)
vii)Pacemaker carrier.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Araki

Organization

Kumamoto University, Faculty of Life Sciences

Division name

Metabolic Medicine

Zip code


Address

1-1-1 Honjo, Kumamoto

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

Kumamoto University, Faculty of Life Sciences

Division name

Metabolic Medicine

Zip code


Address

1-1-1 Honjo, Chuo-ku, Kumamoto

TEL

096-373-5169

Homepage URL


Email

t-kondo@gpo.kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University, Faculty of Life Sciences, Metabolic Medicine

Institute

Department

Personal name



Funding Source

Organization

Kumamoto University, Faculty of Life Sciences, Metabolic Medicine

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


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

2012 Year 04 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ebiomedicine.com/

Number of participants that the trial has enrolled


Results

Upon HS+MES treatment, glucose homeostasis and inflammatory cytokine levels were significantly improved in MS or T2DM patients.
In circulating monocytes, HS+MES reduced inflammatory signal molecules as well.

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

2012 Year 04 Month 17 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 06 Month 01 Day

Date analysis concluded

2014 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 04 Month 20 Day

Last modified on

2015 Year 04 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009184


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name