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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003320
Receipt No. R000004031
Scientific Title Study for Arrhythmias Associated Blood Pressure, Diabetes Mellitus and Metabolic Syndrome in Fuji district-FUJI Study-
Date of disclosure of the study information 2010/04/01
Last modified on 2016/09/15

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Basic information
Public title Study for Arrhythmias Associated Blood Pressure, Diabetes Mellitus and Metabolic Syndrome in Fuji district-FUJI Study-
Acronym FUJI Study
Scientific Title Study for Arrhythmias Associated Blood Pressure, Diabetes Mellitus and Metabolic Syndrome in Fuji district-FUJI Study-
Scientific Title:Acronym FUJI Study
Region
Japan

Condition
Condition Hypertension, dyslipidemia, diabetes mellitus
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We accumulate medical check data and analyze relations between life style related diseases, BP, lipid level, and glucose level among workers. Also we build up guidance for lifestyle modification among the workers.
Basic objectives2 Others
Basic objectives -Others We explore the relation between arteriosclerosis of funduscopic finding, atrial fibrillation, lipid level and blood pressure.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood pressure, ECG findings, Fatty liver, Funduscopic finding, Spirometry
Key secondary outcomes Complete Blood Count, Biochemistry, Urinalysis

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Workers employed in Fuji-City district companies which commit medical checks to Fuji-Kenshin-Center.
Key exclusion criteria none
Target sample size 8000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Mori
Organization Yokohama Sotetsu bldg Clinic of Internal Medicine
Division name Yokohama Sotetsu bldg Clinic of Internal Medicine
Zip code
Address Sotetsu KS bldg 2 F, 1-11-5, Kitasaiwai, Nishi-Ku, Yokohama, Japan
TEL 045-311-3827
Email hmori@gem.hi-ho.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisao Mori
Organization Yokohama Sotestu bldg Clinic of Internal Medicine
Division name Yokohama Sotestu bldg Clinic of Internal Medicine
Zip code
Address Sotetsu KS bldg 2 F, 1-11-5, Kitasaiwai, Nishi-Ku, Yokohama, Japan
TEL 045-311-3827
Homepage URL http://www.sotetsu-naika.com
Email hmori@gem.hi-ho.ne.jp

Sponsor
Institute Yokohama Sotetsu bldg Clinic of Internal Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 富士健診センター(静岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 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
2009 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The relationships between life style, hypertension, dyslipidemia and diabetes mellitus were established. From the standpoint of vascular diseases cigarette smoking, obesity and other wrong life habits develop risks of vascular diseases. There are many problems about improving life style modification including shift working. Our pilot study revealed smoking rate was lower in the elder group than in the younger one but the smoking rate of operating officers was high and program to stop smoking is needed to start from senior workers in the companies. Morbidity of atrial fibrillation was 2% in 2006 but the rate was increased to 5% in 2008. Thus accumulation of health check data and adequate analysis are important to improve life style related diseases.

Management information
Registered date
2010 Year 03 Month 12 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004031

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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