UMIN-ICDS Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Osaka Metropolitan University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

11

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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).

Registered date

2022

Year

11

Month

03

Day

Last modified on

2022

Year

11

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056270