UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062762 |
|---|---|
| Receipt number | R000071856 |
| Scientific Title | The moderating role of pre-transplant steatotic liver disease in the association between psychological aspects of eating behavior and weight gain after liver transplantation: a cross-sectional study |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/09/01 11:25:07 |
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Basic information
Public title
The moderating role of pre-transplant steatotic liver disease in the association between psychological aspects of eating behavior and weight gain after liver transplantation: a cross-sectional study
Acronym
The moderating role of pre-transplant steatotic liver disease in the association between psychological aspects of eating behavior and weight gain after liver transplantation: a cross-sectional study
Scientific Title
The moderating role of pre-transplant steatotic liver disease in the association between psychological aspects of eating behavior and weight gain after liver transplantation: a cross-sectional study
Scientific Title:Acronym
The moderating role of pre-transplant steatotic liver disease in the association between psychological aspects of eating behavior and weight gain after liver transplantation: a cross-sectional study
Region
| Japan |
Condition
Condition
steatotic liver disease
Classification by specialty
| Endocrinology and Metabolism | Hepato-biliary-pancreatic surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the moderating effect of pre-transplant steatotic liver disease on the association between psychological aspects of eating behavior and weight gain after liver transplantation.
Basic objectives2
Others
Basic objectives -Others
To explore factors associated with weight gain and steatotic liver disease after liver transplantation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
weight change
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who underwent liver transplantation at 18 years of age or older
(2) Liver transplant recipients who are between six months and five years post-transplant
(3) Individuals who can read and write Japanese
Key exclusion criteria
(1) Pregnant women
(2) Patients undergoing treatment for malignant tumors (other than skin cancer) or recurrent hepatocellular carcinoma after liver transplantation
(3) Patients awaiting liver transplantation
(4) Patients who underwent a re-transplant or multi-organ transplant
(5) Patients who are ineligible for study participation based on the judgment of doctors and researchers
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Nin |
Organization
Graduate School of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3946
nin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Minakata |
Organization
Graduate School of Medicine, Kyoto University
Division name
Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3946
Homepage URL
minakata.saki.33a@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2026 | Year | 11 | Month | 15 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071856
