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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025082
Receipt No. R000028783
Scientific Title A cohort study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease
Date of disclosure of the study information 2016/12/22
Last modified on 2017/10/18

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Basic information
Public title A cohort study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease
Acronym A cohort 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
Scientific Title:Acronym A cohort study of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease
Region
Japan

Condition
Condition Subjects with metabolic syndrome
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Laboratory medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The investigation of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease
Basic objectives2 Others
Basic objectives -Others The investigation of the association between quality of fat and digestive system diseases including nonalcoholic fatty liver disease in subjects with metabolic syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The predictor of nonalcoholic fatty liver disease in subjects with MS
Key secondary outcomes 1. The prevalence of nonalcoholic fatty liver disease in subjects with MS
2. The prevalence of various digestive system diseases in subjects with MS
3. The predictor of various digestive system diseases in subjects with MS

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects with metabolic syndrome
Key exclusion criteria <Subjects who fulfill the exclusion criteria for nonalcoholic fatty liver disease>
1 Subjects who were positive for hepatitisB 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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiya Okahisa
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Department of General Medicine and Community Health Science
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima city
TEL 088-633-7124
Email okahisa5505@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Sogabe
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Department of General Medicine and Community Health Science
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima city
TEL 088-633-7124
Homepage URL
Email sogabe.masahiro@tokushima-u.ac.jp

Sponsor
Institute Shikoku Central Hospital of the Mutual aid Association of Public School teachers
Institute
Department

Funding Source
Organization MEXT (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 22 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
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
Other related information The investigation of the association between metabolic syndrome and digestive system diseases including nonalcoholic fatty liver disease

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

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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