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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name