UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055046 |
|---|---|
| Receipt number | R000062883 |
| Scientific Title | The significance of steatotic liver disease in metabolic syndrome-related diseases |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/07/10 09:56:06 |
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Basic information
Public title
The significance of steatotic liver disease in metabolic syndrome-related diseases
Acronym
The significance of steatotic liver disease in metabolic syndrome-related diseases
Scientific Title
The significance of steatotic liver disease in metabolic syndrome-related diseases
Scientific Title:Acronym
The significance of steatotic liver disease in metabolic syndrome-related diseases
Region
| Japan |
Condition
Condition
steatotic liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the causal relationship between steatotic liver disease and the onset of metabolic syndrome
Basic objectives2
Others
Basic objectives -Others
To examine whether improving steatotic liver disease can prevent the onset of metabolic syndrome
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate the significance of steatotic liver disease for the onset of metabolic syndrome-related diseases in non-metabolic syndrome-related disease patients
Key secondary outcomes
To explore the effect of improving steatotic liver disease on metabolic syndrome-related diseases in patients with fatty liver
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases in which the presence or absence of steatotic liver (diagnosed by ultrasound examination) was diagnosed among the same health checkup recipients (first year, seven years later)
Key exclusion criteria
Those who have not undergone a medical checkup in the first year or seven years after the examination, or have not undergone an ultrasound examination in either year
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kamada |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Metabolic Hepatology
Zip code
5650871
Address
1-7, Yamadaoka, Suita, Osaka
TEL
0668792561
ykamada@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kamada |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Advanced Metabolic Hepatology
Zip code
5650871
Address
1-7, Yamadaoka, Suita,
TEL
0668792561
Homepage URL
https://www.med.osaka-u.ac.jp/pub/advancedgh/index.html
ykamada@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Yoshihiro Kamada
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nippon Boehringer Ingelheim
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
1-7, Yamadaoka, Suita
Tel
0668795111
ykamada@sahs.med.osaka-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
大阪大学大学院医学系研究科
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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
714
Results
1, SLD in the first year is an independent factor for the incidence of T2DM, HT, and DL 7 years later.
2, T2DM and HT are not independent factors for the incidence of SLD 7 years later. DL and obesity, is an independent factor for the incidence of SLD.
3, Each MetS-related disease is not an independent factor for the development of SLD.
4, From the above, the presence or absence of SLD is a greater risk factor for the development of each MetS-related disease than obesity.
Results date posted
| 2025 | Year | 07 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 07 | Month | 10 | Day |
Baseline Characteristics
1, 714 patients who visited the health check-up center in the first year and then again 7 years later
2, Steatotic liver disease and metabolic syndrome-related diseases (T2D, HT, DL) were assessed in the first year and 7 years later
3. The diagnostic criteria for each disease were as follows.
Steatotic liver disease
1, Steatotic liver disease findings in abdominal ultrasound examination by an experienced examiner (positive liver-renal contrast in echogenicity, deep attenuation of ultrasound, blurred vascular image)
Type 2 diabetes (T2D)
1, FBS 126mg/dL or more or HbA1c 6.5% or more
2, Taking oral diabetes medication
Hypertension (HT)
1, Systolic blood pressure 140mmHg or more or diastolic blood pressure 90mmHg or more
2, Taking oral hypertension medication
Dyslipidemia (DL)
1, TG value 150mg/dL or more or HDL-C less than 40mg/dL (both men and women)
2, Taking oral dyslipidemia medication
Participant flow
1, 714 patients underwent health checkups in the first year and seven years later.
2, Steatotic liver disease and metabolic syndrome-related diseases (type 2 diabetes, hypertension, diabetic nephropathy) were evaluated in the first year and seven years later.
Adverse events
none
Outcome measures
1, Subjects who were disease-free in the first year and developed disease after 7 years were defined as incident cases.
2, Multivariate analysis was used to determine which factors in the first year contributed to the onset or onset of disease after 7 years.
3, JMP Pro 17.2 was used for statistical analysis.
4, Analysis of variance and Wilcoxon test were used for statistical analysis. For categorical factors, chi-square test was performed.
5, Variables were divided into two groups based on category and multivariate analysis was performed using logistic regression analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study that retrospectively analyzes data from subjects who have already completed their health checkups. Data entry has already been completed, and analysis is now underway.
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062883
