UMIN-CTR Clinical Trial

Basic information
Public title	A Registry Study of the Epidemiology of Metabolic Syndrome, Fatty Liver, and CKD in the Japanese Population
Acronym	Registry Study on the Epidemiology of the Metabolic Syndrome in the Japanese
Scientific Title	Medical health checkup registry for metabolic syndrome, chronic kidney disease, and fatty liver in Japan
Scientific Title:Acronym	MIRACLE-J
Region	Japan

Condition
Condition	Metabolic syndrome, fatty liver, and CKD
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Endocrinology and Metabolism Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the epidemiological characteristics of metabolic syndrome, fatty liver including NAFLD (non-alcoholic fatty liver disease)/MAFLD (metabolic disorder-related fatty liver) and CKD (chronic kidney disease) in Japan by registering the examinees of Japanese National Health Checkup and Health Examination Program and creating a registry.
Basic objectives2	Others
Basic objectives -Others	Registry Study
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Not set
Key secondary outcomes	(1) Frequency of metabolic syndrome (2) Frequency of NAFLD and MAFLD, percentage by gender and BMI (3) Proportion of patients with advanced fibrosis according to cutoff value of FIB-4 by age (4) CKD stage and percentage (5) Variations in various test items among those who visited the hospital during the first year and visited again after a certain period of time (6) Association of the above items with biochemical data related to lifestyle-related diseases, abdominal echocardiographic findings, medical interview and disease data

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	95 years-old >=
Gender	Male and Female
Key inclusion criteria	1. those who received physical examinations and health checkup services at MedCity21, a clinic affiliated with the Department of Premier Preventive Medicine, Osaka Metropolitan University Hospital, or a collaborating research institute between April 2014 and March 2032 2. be at least 18 years of age at the time of initial consent
Key exclusion criteria	nothing in particular
Target sample size	1200000

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Fujii
Organization	Graduate School of Medicine, Osaka Metropolitan University
Division name	Department of Hepatology
Zip code	545-8585
Address	1-4-3, Asahimachi Abeno-ku, Osaka, Japam
TEL	+81-6-6645-3905
Email	rolahideki@omu.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Fujii
Organization	Graduate School of Medicine, Osaka Metropolitan University
Division name	Department of Hepatology
Zip code	545-8585
Address	1-4-3, Asahimachi Abeno-ku, Osaka, Japan
TEL	+81-6-66645-3905
Homepage URL
Email	rolahideki@omu.ac.jp

Sponsor
Institute	Graduate School of Medicine, Osaka Metropolitan University
Institute
Department

Funding Source
Organization	self funding
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	Ethics Committee, Graduate School of Medicine, OsakaMetropolitan University
Address	6F Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka City, Osaka
Tel	06-6645-3456
Email	gr-a-knky-ethics@omu.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	2022 Year 11 Month 04 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	Enrolling by invitation
Date of protocol fixation	2022 Year 08 Month 22 Day
Date of IRB	2022 Year 09 Month 14 Day
Anticipated trial start date	2022 Year 09 Month 22 Day
Last follow-up date	2032 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 will build on existing information collected in a previous study, "A Multi-institutional, backward-looking observational study on the epidemiology of NAFLD and CKD in Japanese (Osaka Metropolitan University Medical School Ethics Review Committee Approval Number 2019-101, Approval Date August 20, 2020).

Management information
Registered date	2022 Year 11 Month 03 Day
Last modified on	2022 Year 11 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056270