UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017735 |
|---|---|
| Receipt number | 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 19:30:20 |
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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
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
naoki.kumashiro@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/20541
