UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058227 |
|---|---|
| Receipt number | R000066565 |
| Scientific Title | Study of Seven Kanto Prefectures Using the National Database |
| Date of disclosure of the study information | 2025/06/19 |
| Last modified on | 2025/06/19 19:20:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of Seven Kanto Prefectures Using the National Database
Acronym
NDB-K7Ps Study
Scientific Title
Study of Seven Kanto Prefectures Using the National Database
Scientific Title:Acronym
NDB-K7Ps Study
Region
| Japan |
Condition
Condition
Non-communicable diseases (diabetes, hypertension, dyslipidemia, hyperuricemia, chronic kidney disease)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Neurology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Laboratory medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current states of cardiometabolic diseases and other conditions and the underlying mechanisms, we examine the data of the NDB (about specific health checkups, diagnosed diseases and prescribed medicine) in the seven prefectures (Tokyo, Kanagawa, Saitama, Chiba, Ibaraki, Gunma, and Tochigi) of Japan's Kanto region.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between obesity, low body weight and metabolic syndrome and Non-communicable diseases (diabetes, hypertension, dyslipidemia, hyperuricemia, chronic kidney disease)
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who underwent health check-ups for 2008-2018 in the Kanto 7 Prefectures
Key exclusion criteria
None
Target sample size
10000000
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Nakajima |
Organization
Japan Women's University
Division name
Dept. of Nutritional Science, Faculty of Food and Nutritional Sciences
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku
TEL
03-5981-3427
nakajimak@fc.jwu.ac.jp
Public contact
Name of contact person
| 1st name | Airi |
| Middle name | |
| Last name | Sekine |
Organization
Japan Women's University
Division name
Dept. of Nutritional Science, Faculty of Food and Nutritional Sciences
Zip code
112-8681
Address
2-8-1, Mejirodai, Bunkyo-ku
TEL
03-5981-3427
Homepage URL
https://mcm-www.jwu.ac.jp/~NDB-K7Ps/blog/
nakajimak@fc.jwu.ac.jp
Sponsor or person
Institute
Japan Women's University
Institute
Department
Personal name
Kei Nakajima
Funding Source
Organization
The Research Institute in Japan Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee for experimental research involving human subjects, Japan Women's University
Address
2-8-1, Mejirodai, Bunkyo-ku
Tel
03-5981-3775
n-shien@atlas.jwu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2320
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本女子大学 食科学部栄養学科
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10183619
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 12 | Day |
Other
Other related information
Study design: cross-sectional and cohort study
Subjects: subjects aged 40-74 who underwent health check-ups for 2008-2018 in the seven prefectures (Tokyo, Kanagawa, Saitama, Chiba, Ibaraki, Gunma, and Tochigi) of Japan's Kanto region. The sample size ranged from 7 million to 10 million people annually.
Available data in this research: Clinical data from specific health checkups, diagnosed diseases and prescribed medication
Management information
Registered date
| 2025 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066565
