UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045884 |
|---|---|
| Receipt number | R000052383 |
| Scientific Title | Association between glycemic profile and chewing problems among older community-dwelling individuals in Japan: A prospective study |
| Date of disclosure of the study information | 2021/10/27 |
| Last modified on | 2025/10/31 07:59:06 |
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Basic information
Public title
Association between glycemic profile and chewing problems among older community-dwelling individuals in Japan: A prospective study
Acronym
Association between glycemic profile and chewing problems among older community-dwelling individuals in Japan: A prospective study
Scientific Title
Association between glycemic profile and chewing problems among older community-dwelling individuals in Japan: A prospective study
Scientific Title:Acronym
Association between glycemic profile and chewing problems among older community-dwelling individuals in Japan: A prospective study
Region
| Japan |
Condition
Condition
Subjects receiving annual health check
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between glycemic profile and chewing problems among older community-dwelling individuals in Japan
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between glycemic profile and chewing problems among older community-dwelling individuals in Japan
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects aged 65 years and above who had undergone health checkup at Nihon University hospital between January 2022 and December 2019.
Key exclusion criteria
(1) Subjects who answered "I sometimes have difficulty in chewing food because of problems with my teeth, gums, occlusion or the like." or "I can hardly chew food." to the self report questionnaires.
(2) Missing data of plasma glucose or glycated hemoglobin.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Department of Internal Medicine
Zip code
101-8309
Address
1-6 Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
fujishiro.midori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | MIdori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Department of Internal Medicine
Zip code
101-8309
Address
1-6 Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL
03-3293-1711
Homepage URL
fujishiro.midori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Nihon University Hospital
Address
1-6 Kandasurugadai, Chiyoda-ku, Tokyo, Japan
Tel
03-3293-1711
nuhosp.rinri@nihon-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
| 2021 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not in particular
Management information
Registered date
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052383
