UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026628 |
|---|---|
| Receipt number | R000030530 |
| Scientific Title | The effect of short durtaion diet program for the liver transplantation donor with liver steatosis |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2024/09/25 12:43:39 |
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Basic information
Public title
The effect of short durtaion diet program for the liver transplantation donor with liver steatosis
Acronym
The short durtaion diet program for the donor with liver steatosis
Scientific Title
The effect of short durtaion diet program for the liver transplantation donor with liver steatosis
Scientific Title:Acronym
The short durtaion diet program for the donor with liver steatosis
Region
| Japan |
Condition
Condition
liver steatosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficay of diet program for the transplanatation donor with liver steatosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of liver stetaosis by diet program(8week~24week)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
diet program(8week~24 week)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,gender male and female
2,outpatients
3,moderate steatosis by US or more than 33% steatosis by liver biopsy
Key exclusion criteria
patients with other liver disease (AIH, PBC, active viral hepatitis)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhikoa Nakao |
Organization
Nagasaki University hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Sakamoto 1-7-1, Nagasaki
TEL
095-819-7481
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hisamitsu miyaaki |
Organization
Nagasaki University hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Sakamoto 1-7-1, Nagasaki
TEL
095-819-7481
Homepage URL
miyaaki-hi@umin.ac.jp
Sponsor or person
Institute
Nagasaki University hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030530
