UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052544 |
|---|---|
| Receipt number | R000059910 |
| Scientific Title | Aichi Workers' Cohort Study |
| Date of disclosure of the study information | 2023/10/19 |
| Last modified on | 2024/04/22 08:31:58 |
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Basic information
Public title
Aichi Workers' Cohort Study
Acronym
Aichi Workers' Cohort Study
Scientific Title
Aichi Workers' Cohort Study
Scientific Title:Acronym
Aichi Workers' Cohort Study
Region
| Japan |
Condition
Condition
Coronary artery disease, stroke, cardiovascular disease, atrial fibrillation, cancer, diabetes, hypertension, dyslipidemia, hyperuricemia, obesity, metabolic syndrome, fatty liver, cognitive function, renal function, respiratory function, frailty, mental and psychological status, and others
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Geriatrics | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate factors related to the onset of non-communicable diseases such as cardiovascular diseases and diabetes through a long-term cohort study of employees and retirees in a worksite in Japan
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular diseases, Diabetes
Key secondary outcomes
All diseases or conditions listed in the Condition
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Employees of a worksite in the Chubu region of Japan
Key exclusion criteria
None
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Yatsuya |
| Middle name | |
| Last name | Hiroshi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Public Health and Health Systems
Zip code
466-8550
Address
65 Tsurumai-Cho, Shouwa-Ku, Nagoya-Shi, Aichi, Japan
TEL
0527442128
h828@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yatsuya |
| Middle name | |
| Last name | Hiroshi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Public Health and Health Systems
Zip code
466-8550
Address
65 Tsurumai-Cho, Shouwa-Ku, Nagoya-Shi, Aichi, Japan
TEL
0527442128
Homepage URL
https://koei-nagoya.blogspot.com/
h828@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Yatsuya Hiroshi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujita Health University, National Center for Geriatric and Gerontology, Others
Name of secondary funder(s)
Ministry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
Ethics Review Committee, Nagoya University Graduate School of Medicine
Address
65 Tsurumai-Cho, Shouwa-Ku, Nagoya-Shi, Aichi, Japan
Tel
0527412111
ethics@med.nagoya-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
| 2023 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
https://koei-nagoya.blogspot.com/
Publication of results
Partially published
Result
URL related to results and publications
https://koei-nagoya.blogspot.com/
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
Baseline characteristics of the 2023 survey is presented in the following website:
https://koei-nagoya.blogspot.com/
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2043 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Aichi Workers' Cohort Study is a prospective cohort study that collected a multitude of variables from self-reported questionnaire, health check-up and stored biological samples. They include factors such as lifestyle habits (physical activity, diet and nutrition, sleep, smoking, alcohol consumption, stress, fatigue, etc.), body weight, blood pressure, blood and urine laboratory data, geographical information, biomarkers such as insulin and adipocytokine, genetic information, and epigenomic analysis results. The associations of these variables with target conditions are examined. This cohort study is a dynamic cohort study with multiple baseline surveys conducted in 1997, 2002, 2007, 2013, 2018 and 2023. And, health check-up data have longitudinally been collected. Date of protocol fixation, Date of IRB, Anticipated trial start date registered above is for the latest survey (2023).
Management information
Registered date
| 2023 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059910
| 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 |
