UMIN-CTR Clinical Trial

Public title

A cohort study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease at medical check up

Acronym

A study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease

Scientific Title

A cohort study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease at medical check up

Scientific Title:Acronym

A study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease

Region

Japan

Condition

Subjects who underwent a medical checkup and subjects with metabolic syndrome

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The investigation of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease at medical checkup

Basic objectives2

Others

Basic objectives -Others

The investigation of the association between various background factors and digestive system diseases including nonalcoholic fatty liver disease in subjects with metabolic syndrome

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The predictor of nonalcoholic fatty liver disease in subjects who underwent a medical checkup

Key secondary outcomes

1. The prevalence of nonalcoholic fatty liver disease in subjects who underwent a medical checkup or subjects with MS
2. The predictor of nonalcoholic fatty liver disease in subjects who underwent a medical checkup or subjects with MS
3. The prevalence of various digestive system diseases in subjects who underwent a medical checkup or subjects with MS
4. The predictor of various digestive system diseases in subjects who underwent a medical checkup or subjects with MS

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who underwent a medical checkup or subjects with metabolic syndrome

Key exclusion criteria

<Subjects who fulfill the exclusion criteria for nonalcoholic fatty liver disease>
1. Subjects who were positive for hepatitis B surface antigen
2. Subjects who were positive for hepatitis C antibody
3. Subjects who had a history of various hepatic disorders
4. Subjects who consumed 20 g/day or more of alcohol
5. Subjects who had a malignant tumor
<Subjects who fulfill the exclusion criteria for various digestive system diseases excluding nonalcoholic fatty liver disease>
1. Subjects who had a history of digestive organ surgery
2. Subjects who had a malignant tumor

Target sample size

10000

Name of lead principal investigator

1st name	Toshiya
Middle name
Last name	Okahisa

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Department of General Medicine and Community Health Science

Zip code

770-8503

Address

3-18-15 Kuramoto-cho, Tokushima city

TEL

088-633-7124

Email

okahisa5505@tokushima-u.ac.jp

Name of contact person

1st name	Masahiro
Middle name
Last name	Sogabe

Organization

Health Service Office, Health Service, Counseling and Accessibility Center, Tokushima University

Division name

Health Service

Zip code

770-8502

Address

1-1 Minamijyosanjima-cho, Tokushima city

TEL

088-656-7289

Homepage URL

Email

sogabe.masahiro@tokushima-u.ac.jp

Institute

Shikoku Central Hospital of the Mutual aid Association of Public School teachers

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of the Shikoku Central Hospital of the Mutual Aid Association of Public School Teachers

Address

2233 Kawanoe-cho, Shikokuchuo city, Ehime 799-0193

Tel

0896-58-3515

Email

soumu@shikoku-ctr-hsp.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

2016

Year

12

Month

26

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

2016

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The investigation of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease at medical checkup

The investigation of the association between various background factors and digestive system diseases including nonalcoholic fatty liver disease in subjects with metabolic syndrome

Registered date

2016

Year

12

Month

05

Day

Last modified on

2023

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028915