UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054481 |
|---|---|
| Receipt number | R000061863 |
| Scientific Title | Investigation of the oral environment of Japanese type 2 diabetes patients |
| Date of disclosure of the study information | 2024/05/25 |
| Last modified on | 2024/05/24 16:49:16 |
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Basic information
Public title
Survey of the oral environment of patient with Type 2 diabetes mellitus in Japan
Acronym
Survey of the oral environment
Scientific Title
Investigation of the oral environment of Japanese type 2 diabetes patients
Scientific Title:Acronym
Oral environment survey of Japanese patients with type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Oral survey of Japanese type 2 diabetic patients and examination of the relationship between periodontal disease and blood sugar control status
Basic objectives2
Others
Basic objectives -Others
Oral self-care interview
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Periodontal disease evaluation using CPI and measurement of HbA1c value
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
Periodontal disease evaluation using CPI
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients with type 2 diabetes attending hospital
Key exclusion criteria
Non
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Kurinami Clinic
Division name
Internal Medicine
Zip code
842-0006
Address
76-1 Edagari Kanzaki-Town , Kanzaki-City, Saga Japan
TEL
0952522977
kurinami@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | NOBORU |
| Middle name | |
| Last name | KURINAMI |
Organization
Kurinami Clinic
Division name
Internal Medicine
Zip code
842-0006
Address
76-1 Edagari Kanzaki-Town , Kanzaki-City, Saga Japan
TEL
0952522977
Homepage URL
kurinami.iin@gmail.com
Sponsor or person
Institute
Kurinami Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Jinnouchi Hospital
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
Tel
096-363-0011
hisyo@jinnouchi.or.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
| 2024 | Year | 05 | Month | 25 | 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
162
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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061863
