UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for Arrhythmias Associated Blood Pressure, Diabetes Mellitus and Metabolic Syndrome in Fuji district-FUJI Study-
Title of the study (Brief title)	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	Hisao Mori
Organization	Yokohama Sotetsu bldg Clinic of Internal Medicine
Division name	Yokohama Sotetsu bldg Clinic of Internal Medicine
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	Hisao Mori
Organization	Yokohama Sotestu bldg Clinic of Internal Medicine
Division name	Yokohama Sotestu bldg Clinic of Internal Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2009 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004031