UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054992 |
|---|---|
| Receipt number | R000062830 |
| Scientific Title | The Effect of Physical Activity and Dietary Intake on Liver Fat Content in Healthy Adults and Patients with Non-alcoholic Fatty Liver Disease: A Retrospective Observational Study Using Established Data |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/07/17 14:27:01 |
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Basic information
Public title
Development of Methods for Prevention, Diagnosis, and Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Acronym
Development of Methods for Prevention, Diagnosis, and Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Scientific Title
The Effect of Physical Activity and Dietary Intake on Liver Fat Content in Healthy Adults and Patients with Non-alcoholic Fatty Liver Disease: A Retrospective Observational Study Using Established Data
Scientific Title:Acronym
The Effect of Physical Activity and Dietary Intake on Liver Fat Content in Healthy Adults and Patients with Non-alcoholic Fatty Liver Disease: A Retrospective Observational Study Using Established Data
Region
| Japan |
Condition
Condition
Non-alcoholic Fatty Liver Disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A retrospective statistical analysis will be conducted using established data to investigate the effect of physical activity and dietary intake on liver fat content, as assessed by the FibroScan controlled attenuation parameter, in healthy adults and patients with non-alcoholic fatty liver disease.
Basic objectives2
Others
Basic objectives -Others
A retrospective statistical analysis will be conducted using established data to determine the effect of physical activity and dietary intake on the association with liver fibrosis indicators (liver stiffness measurement [LSM] by FibroScan, fibrosis markers, fibrosis scores), liver function, insulin resistance, vital signs, and physical findings in healthy adults and patients with non-alcoholic fatty liver disease (NAFLD).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Liver Imaging Diagnosis
Key secondary outcomes
Study Subjects Background, Physical Findings, Body Composition, Vital Signs, Dietary Intake, Physical Activity Levels, Hematological Tests, Blood Biochemical Tests, Endocrinological Tests, Immunoserological Tests, General Tests, NAFLD-Related Scores
Base
Study type
Others,meta-analysis etc
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects will be selected from clinical research participants aged 20 and older between 2009 and 2021, and these data will be pooled for statistical analysis.
Key exclusion criteria
Data with missing values in the main outcome measures will be excluded.
Target sample size
925
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Isobe |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Medical Physics
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-7834
tiso@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Sechang |
| Middle name | |
| Last name | Oh |
Organization
R Professional University of Rehabilitation
Division name
Rehabilitation
Zip code
300-0032
Address
2-10-35 Kohoku, Tsuchiura, Ibaraki, Japan
TEL
029-824-7611
Homepage URL
o-sechan@u.a-ru.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
R Professional University of Rehabilitation
Name of secondary funder(s)
EA Pharma Co., Ltd.
IRB Contact (For public release)
Organization
Office of the Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3308
sien.igakuss@un.tsukuba.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
| 2025 | Year | 04 | Month | 01 | 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
925
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a joint retrospective observational research conducted at the University of Tsukuba, R Professional University of Rehabilitation and EA Pharma Co., Ltd. using only the existing data collected at the University of Tsukuba.
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062830
