UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016266 |
|---|---|
| Receipt number | R000018819 |
| Scientific Title | Risk assessment of lifestyle related diseases by genetic diagnosis |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2026/07/29 11:19:41 |
* 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
Risk assessment of lifestyle related diseases by genetic diagnosis
Acronym
Risk assessment of lifestyle related diseases by genetic diagnosis
Scientific Title
Risk assessment of lifestyle related diseases by genetic diagnosis
Scientific Title:Acronym
Risk assessment of lifestyle related diseases by genetic diagnosis
Region
| Japan |
Condition
Condition
Lifestyle related disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the genetic information and interaction between gene and environment to develop lifestyle related diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of lifestyle related diseases
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Annual health examination participants of Toyota Motor Co., Ltd. who consented to DNA sampling.
Key exclusion criteria
none
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Seiichi |
| Middle name | |
| Last name | Matsuo |
Organization
Nagoya University Graduate school of medicine
Division name
Department of Nephrology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2182
smatsuo@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shoichi |
| Middle name | |
| Last name | Maruyama |
Organization
Nagoya University Graduate school of medicine
Division name
Department of Nephrology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya city
TEL
052-744-2192
Homepage URL
marus@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Toyota Motor Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-741-2111
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
名古屋大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.pme.coe.nagoya-u.ac.jp/document2/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/27245511/
Number of participants that the trial has enrolled
6750
Results
Among Japanese male workers, we investigated the interplay between lifestyle factors and genetic polymorphisms and their associations with obesity, hypertension, and kidney function. We demonstrated that polymorphisms in BRAP and GHRL modified the association between dietary energy intake and obesity-related traits. In contrast, hypertension-susceptibility polymorphisms influenced the relationship between dietary salt intake and blood pressure.
Results date posted
| 2026 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
These studies were conducted using data from the PME cohort, an ongoing occupational cohort established through collaboration between Nagoya University and industry. The cohort consists primarily of Japanese male workers who underwent annual health examinations and completed standardized lifestyle questionnaires. Comprehensive data, including anthropometric measurements, blood pressure, biochemical parameters, dietary intake, lifestyle habits, and genomic information, were collected, enabling integrated analyses of gene-environment interactions. This well-characterized cohort has been widely utilized to investigate the genetic and environmental determinants of obesity, hypertension, chronic kidney disease, and other lifestyle-related diseases.
Participant flow
Japanese workers participating in the Project for Medical Engineering (PME) cohort were recruited during annual health examinations after providing informed consent. Anthropometric measurements, blood and urine tests, lifestyle and dietary questionnaires, and DNA samples were collected. For each study, participants with missing data or those not meeting the study-specific eligibility criteria were excluded, and the final analytical cohort was established. Cross-sectional analyses were then performed to evaluate the interactions between genetic polymorphisms and lifestyle factors in relation to obesity, blood pressure, and kidney function.
Adverse events
No adverse event
Outcome measures
The primary outcomes included obesity-related traits, blood pressure, and kidney function. Associations between these outcomes and genetic polymorphisms, dietary energy intake, salt intake, and their gene-environment interactions were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data acquisition of health examination, meal-check system, and genetic information associated with lifestyle related diseases.
Management information
Registered date
| 2015 | Year | 01 | Month | 19 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018819
