UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006230 |
|---|---|
| Receipt number | R000007366 |
| Scientific Title | A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease |
| Date of disclosure of the study information | 2011/08/25 |
| Last modified on | 2017/03/01 07:07:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Acronym
Risk Factors of NAFLD
Scientific Title
A Prospective observational study to elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease
Scientific Title:Acronym
Risk Factors of NAFLD
Region
| Japan |
Condition
Condition
Healthy people who receive medical checkup
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the risk factors that contribute to development of non-alcoholic fatty liver disease (NAFLD).
Basic objectives2
Others
Basic objectives -Others
To clarify the incidence of NAFLD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of NAFLD.
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
1.Age equal to 20 or over 20 years old.
2.No evidence of HCV, HBV, or syphilis infection.
3.Taking alcohol less than 20g/day.
4.Diagnosis of fatty liver.
Key exclusion criteria
1.Patients reject to participate into this study.
2.Follow up period less than a year.
3.Patients who were ruled unfit to this study for any other reasons.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorial Hospital
Department of Gastroenterology
Division name
Department of Gastroenterology
Zip code
Address
Kanda-izumicho Ichi-banchi Chiyoda ward Tokyo Japan
TEL
03-3862-9111
anb72547@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorial Hospital
Division name
Department of Gastroenterology
Zip code
Address
Kanda-izumicho Ichi-banchi Chiyoda ward Tokyo Japan
TEL
03-3862-9111
Homepage URL
anb72547@nifty.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Mitsui Memorial Hospital
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
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
三井記念病院、三井記念病院健診センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Open for registration.
Management information
Registered date
| 2011 | Year | 08 | Month | 25 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007366
