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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007582
Receipt No. R000008867
Scientific Title Association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis
Date of disclosure of the study information 2012/04/01
Last modified on 2012/03/27

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Basic information
Public title Association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis
Acronym Association between nesfatin1 and visceral fat using dual impedance analysis
Scientific Title Association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis
Scientific Title:Acronym Association between nesfatin1 and visceral fat using dual impedance analysis
Region
Japan

Condition
Condition diabetes mellitus, borderline diabetes, obesity, fatty liver, metabolic syndrome
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis.
Basic objectives2 Others
Basic objectives -Others We measure visceral fat using dual impedance analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who agreed to this study via sufficient informed concent.

Patient who has any of the following.
1. diabetes mellitus
2. borderline diabetes
3. obesity
4. fatty liver
5. metabolic syndrome
Key exclusion criteria Patient who has any of the following.
1.pregnant woman
2.woman who may pregnant
3.renal failure
4.hemodialysis patient
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Takahashi
Organization Gunma University
Division name department of endocrinology and diabetes
Zip code
Address 3-39-15 Showa, Maebashi, Gumma, 371-8511 Japan
TEL 027-220-7111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Takahashi
Organization Gunma University
Division name department of endocrinology and diabetes
Zip code
Address 3-39-15 Showa, Maebashi, Gumma, 371-8511 Japan
TEL 027-220-7111
Homepage URL
Email hirokit@showa.gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma 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
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 群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 04 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 Preinitiation
Date of protocol fixation
2012 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 09 Month 01 Day

Other
Other related information We investigate the association between waist circumference, insulin resistance, nesfatin1 and visceral fat using dual impedance analysis.

Management information
Registered date
2012 Year 03 Month 27 Day
Last modified on
2012 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008867

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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