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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001149
Receipt No. R000001396
Scientific Title Amelioration of glucose homeostasis and visceral adiposity in metabolic syndrome by mild electrical current and thermo therapy
Date of disclosure of the study information 2008/06/01
Last modified on 2010/01/14

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Basic information
Public title Amelioration of glucose homeostasis and visceral adiposity in metabolic syndrome by mild electrical current and thermo therapy
Acronym Metabolic ameliorations in metabolic syndrome by MET
Scientific Title Amelioration of glucose homeostasis and visceral adiposity in metabolic syndrome by mild electrical current and thermo therapy
Scientific Title:Acronym Metabolic ameliorations in metabolic syndrome by MET
Region
Japan

Condition
Condition metabolic syndrome
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 metabolic syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of biomarkers related to metabolic syndrome 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, 40 subjects.
Interventions/Control_2 12 weeks of no treatment, and then 12 weeks of MET (4 times a week, 60 min each time), 40 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
65 years-old >
Gender Male
Key inclusion criteria 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
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 6.5%.
vii)Pacemaker carrier.
Target sample size 80

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, Japan
TEL 096-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Kondo
Organization Graduate School of Medical Sciences,
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
Institute Department of Metabolic Medicine,
Graduate School of Medical Sciences,
Kumamoto University
Institute
Department

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

Other related organizations
Co-sponsor Japanese Red Cross Society, Kumamoto Health Care Center.
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
2008 Year 06 Month 01 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
2008 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 05 Month 09 Day
Last modified on
2010 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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