UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003320 |
|---|---|
| Receipt number | 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 09:45:29 |
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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
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
hmori@gem.hi-ho.ne.jp
Sponsor or person
Institute
Yokohama Sotetsu bldg Clinic of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
