UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062538 |
|---|---|
| Receipt number | R000071587 |
| Scientific Title | Development and validation of a classification model for postprandial blood glucose elevation patterns |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/10 11:39:08 |
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Basic information
Public title
Development and validation of a classification model for postprandial blood glucose elevation patterns
Acronym
Development and validation of a classification model for postprandial blood glucose elevation patterns
Scientific Title
Development and validation of a classification model for postprandial blood glucose elevation patterns
Scientific Title:Acronym
Development and validation of a classification model for postprandial blood glucose elevation patterns
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate a model for predicting postprandial blood glucose elevation patterns.
Basic objectives2
Others
Basic objectives -Others
To develop and validate a model for predicting postprandial blood glucose elevation patterns using a device. Additionally, to evaluate the measurement accuracy of the device.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose level by self-monitoring of blood glucose (SMBG), pulse wave by a non-invasive device, and pulse wave by a watch-type device.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
To measure the blood glucose levels and pulse waves before and after lunch.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Health male and female employees of the Kewpie Group
(2) Aged from 20 to 64 years at the time of providing informed consent
(3) Willing to disclose the results of their regular health checkups
(4) Provided voluntary written informed consent after receiving a full explanation of the study
Key exclusion criteria
(1) Presence of severe medical conditions or psychiatric disorders
(2) Pregnant or lactating women
(3) History of vasovagal reflex during past blood collection or needle puncture
(4) Severe skin diseases or wounds at the planned puncture site
(5) Deemed unsuitable for participation by the principal investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Kono |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
yoshinori_kono@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Mitsunori |
| Middle name | |
| Last name | Matsuzaki |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
182-0002
Address
2-5-7 Sengawacho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
mitsunori_matsuzaki@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@eps.co.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
| 2026 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 10 | Day |
Last modified on
| 2026 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071587
