UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044227 |
|---|---|
| Receipt number | R000050493 |
| Scientific Title | Influence of oral health on frailty in patients with type 2 diabetes aged 75 years |
| Date of disclosure of the study information | 2021/05/17 |
| Last modified on | 2021/05/15 09:55:02 |
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Basic information
Public title
Influence of oral health on frailty in patients with type 2 diabetes aged 75 years or older
Acronym
Influence of oral health on frailty
Scientific Title
Influence of oral health on frailty in patients with type 2 diabetes aged 75 years
Scientific Title:Acronym
Influence of oral health on frailty
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of oral health on frailty in elderly patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between the progress of the frail score and its influencing factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Odds ratio of oral health using oral frailty index-8 for frailty
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes aged 75 years and older
Key exclusion criteria
Patients with gait disturbance
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ishii |
Organization
The University of Tokyo Hospital
Division name
The Department of Geriatric Medicine
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
+81-3-5800-8655
mishiitky@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Ishii |
Organization
The University of Tokyo Hospital
Division name
The Department of Geriatric Medicine
Zip code
113-8655
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
+81-3-5800-8655
Homepage URL
mishiitky@gmail.com
Sponsor or person
Institute
Okamoto Internal Medicine 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
Medical Corporation Seishin-kai
Address
5-2-3 Kogawashinmachi Yaizu City Shizuoka Japan
Tel
+81-54-627-5585
akiya.hara@seishinkai-med.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
| 2021 | Year | 05 | Month | 17 | 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
229
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2021 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050493
