UMIN-CTR Clinical Trial

Basic information
Public title	The assessment of associaed factor for metabolic disease in a community-based Study
Acronym	Associated factor for metabolic disease
Scientific Title	The assessment of associaed factor for metabolic disease in a community-based Study
Scientific Title:Acronym	Associated factor for metabolic disease
Region	Japan

Condition
Condition	metabolic disease
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify undiagnosed cases of metabolic disease and atherosclerotic disease, this study examine the associated factor for diagnosing metabolic disease and atherosclerotic disease, and explore the predictive factors for onset of metabolic disease, atherosclerotic disease, and cancer.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Identify the associated factor for metabolic disease
Key secondary outcomes	1. Identify the associated factor for nonalcoholic fatty liver disease 2. Identify the associated factor for abnormal glucose tolerance 3. Identify the associated factor for dyslipidemia 4. Identify the associated factor for hypertension 5. Identify the associated factor for hyperuricemia 6. Identify the associated factor for metabolic syndrome 7. Identify the associated factor for atherosclerotic disease 8. Explore the predictive factor for onset of nonalcoholic fatty liver disease 9. Explore the predictive factor for onset of abnormal glucose tolerance 10. Explore the predictive factor for onset of dyslipidemia 11. Explore the predictive factor for onset of hypertension 12. Explore the predictive factor for onset of hyperuricemia 13. Explore the predictive factor for onset of metabolic syndrome 14. Explore the predictive factor for onset of atherosclerotic disease

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects undergo annual health check-up.
Key exclusion criteria	The subjects with data points missing.
Target sample size	30000

Research contact person
Name of lead principal investigator	1st name Teruki Middle name Last name Miyake
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
Zip code	7910295
Address	Toon City, Ehime, Japan
TEL	+81899605308
Email	teruki-ygc@umin.ac.jp

Public contact
Name of contact person	1st name Teruki Middle name Last name Miyake
Organization	Ehime University Graduate School of Medicine
Division name	Department of Gastroenterology and Metabology
Zip code	7910295
Address	Toon city, Ehime
TEL	+81899605308
Homepage URL
Email	teruki-ygc@umin.ac.jp

Sponsor
Institute	Ehime 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 of Ehime University Hospital
Address	454 Shitsukawa Toon Ehime japan
Tel	+81899605914
Email	cttc@m.ehime-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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 02 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	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To identify undiagnosed cases of metabolic disease and atherosclerotic disease, this study examine the associated factor for diagnosing metabolic disease and atherosclerotic disease, and explore the predictive factors for onset of metabolic disease, atherosclerotic disease, and cancer.

Management information
Registered date	2017 Year 12 Month 02 Day
Last modified on	2021 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034524