UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057709 |
|---|---|
| Receipt number | R000065940 |
| Scientific Title | The risk prediction for developing lifestyle diseases through non-invasive tests |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2026/03/24 13:19:03 |
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Basic information
Public title
The risk prediction for developing lifestyle diseases through non-invasive tests
Acronym
The risk prediction for developing lifestyle diseases through non-invasive tests
Scientific Title
The risk prediction for developing lifestyle diseases through non-invasive tests
Scientific Title:Acronym
The risk prediction for developing lifestyle diseases through non-invasive tests
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the accuracy of the risk prediction model for developing lifestyle diseases created by combining non-invasive tests
Basic objectives2
Others
Basic objectives -Others
To confirm the accuracy of the risk prediction model for developing lifestyle diseases
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The accuracy of the risk prediction model for developing lifestyle diseases
Key secondary outcomes
The effectiveness of accelerated plethysmography and autonomic nerves in the risk prediction model for developing lifestyle diseases
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female employees of the Glico Group aged of 18-65 years at the date of informed consent
Key exclusion criteria
･Subjects who have an implantable cardioverter defibrillator (ICD) or a medical equipment necessary for life support
･Subject who is pregnant or under lactation, or who is expected to be pregnant during the study
･Subjects who have aneurism
･Subjects who have deep vein thrombosis of lower limb
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Saito |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
090-4003-6652
yasuo.saito@glico.com
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Matsui |
Organization
Ezaki Glico Co., Ltd.
Division name
R&D Laboratory
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
080-2545-5759
Homepage URL
risa.matsui@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5, Utajima, Nishiyodogawa-ku, Osaka, 555-8502, Japan
Tel
+81-6-6477-8793
dl_rinriiinkai_jimukyoku@glico.com
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
| 2025 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000065940
Number of participants that the trial has enrolled
670
Results
No major issues were identified regarding the extrapolability of the accuracy of the risk prediction model for developing lifestyle diseases beyond the original population. The accuracy was maintained even when the model inputs were replaced with simplified non-invasive examinations.
Results date posted
| 2026 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male and female employees of the Glico Group aged of 18-65 years at the date of informed consent
Participant flow
Number of Full Analysis Set: 670
Number of Per Protocol Set: 662
Adverse events
None
Outcome measures
The accuracy of the risk prediction model for developing lifestyle diseases
The effectiveness of accelerated plethysmography and autonomic nerves in the risk prediction model for developing lifestyle diseases
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To confirm the accuracy of the risk prediction model for developing lifestyle diseases
Management information
Registered date
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065940
