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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017735
Receipt No. R000020541
Scientific Title Investigation on how to prevent and treat type 2 diabetes by the tolerance to adiposity
Date of disclosure of the study information 2015/05/29
Last modified on 2019/12/01

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Basic information
Public title Investigation on how to prevent and treat type 2 diabetes by the tolerance to adiposity
Acronym Investigation on the tolerance to adiposity
Scientific Title Investigation on how to prevent and treat type 2 diabetes by the tolerance to adiposity
Scientific Title:Acronym Investigation on the tolerance to adiposity
Region
Japan

Condition
Condition Nonalcoholic fatty liver disease
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to elucidate the life style, gene, or fat disposition that makes it possible to be tolerant to fat, which is the favorable approach in the aged society in which strict diet and exercise are difficult to force.
Basic objectives2 Others
Basic objectives -Others To find a new way to prevent or treat diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Life style, gene, and fat disposition which make it possible to be tolerant to fat
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who are suffered from fatty liver, are suspected to be nonalcoholic fatty liver disease, and need liver biopsy exam will be qualified for this study.
Key exclusion criteria Subjects who are suffered from heart disease, stroke, cancer, cirrhosis,infection, or collagen disease are excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Kumashiro
Organization Toho University Omori Medical Center
Division name Division of Diabetes, Metabolism, and Endocrinology
Zip code 143-8541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Email naoki.kumashiro@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Kumashiro
Organization Toho University Omori Medical Center
Division name Division of Diabetes, Metabolism, and Endocrinology
Zip code 143-8541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 03-3762-4151
Homepage URL
Email naoki.kumashiro@med.toho-u.ac.jp

Sponsor
Institute Toho University Omori Medical Center
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toho University
Address 6-11-1 Omori-nishi Ota-ku
Tel 0337624151
Email naoki.kumashiro@med.toho-u.ac.jp

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
2015 Year 05 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 50
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 Main results already published
Date of protocol fixation
2014 Year 08 Month 15 Day
Date of IRB
2014 Year 08 Month 15 Day
Anticipated trial start date
2014 Year 10 Month 07 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross sectional study about the relationship between adiposity and insulin sensitivity
Sampling will be held as case control study.

Management information
Registered date
2015 Year 05 Month 29 Day
Last modified on
2019 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020541

Research Plan
Registered date File name
2019/12/01 様式1 サイン入り.pdf

Research case data specifications
Registered date File name
2019/12/01 manuscript clean.pdf

Research case data
Registered date File name
2019/12/01 manuscript clean.pdf


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