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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034500
Receipt No. R000038635
Scientific Title A study of diabetic patient's sense of balance
Date of disclosure of the study information 2018/10/28
Last modified on 2019/10/15

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Basic information
Public title A study of diabetic patient's sense of balance
Acronym A study of diabetic patient's sense of balance
Scientific Title A study of diabetic patient's sense of balance
Scientific Title:Acronym A study of diabetic patient's sense of balance
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is whether the sense of balance of diabetic patients in Japan has declined.
Basic objectives2 Others
Basic objectives -Others This is a study which examines what kind of data shows sense of balance.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1,The one-leg standing time with open eyes in a diabetic patient.

Key secondary outcomes 2,Age,Sex,Period of diabetes mellitus, Diabetic complications(including tests), type of Diabetes, blood sugar control, family history and past history.

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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Outpatient of diabetes/Hospitalized Diabetic patients
Key exclusion criteria Pregnancy, High risk of falling, Psychiatry disease like depression, severe dementia, Those who are not judged appropriate by their doctor and Those who do not wish to participate in research
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Izumi
Organization Takagi Hospital
Division name Preventive medicine and Internal medicine
Zip code 831-0016
Address SAKEMI 141-11, OOKAWA city, FUKUOKA, JAPAN
TEL 0944870001
Email kenizumi@kouhoukai.org

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Izumi
Organization Takagi Hospital
Division name Preventive medicine and Internal medicine
Zip code 831-0016
Address SAKEMI 141-11, OOKAWA city, FUKUOKA, JAPAN
TEL 0944870001
Homepage URL
Email kenizumi@kouhoukai.org

Sponsor
Institute Takagi Hospital
Institute
Department

Funding Source
Organization Takagi Hospital
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 Takagi Hospital IRB
Address SAKEMI 141-11, OOKAWA city, FUKUOKA, JAPAN
Tel 0944870001
Email rinri-shinsa@kouhoukai.org

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
2018 Year 10 Month 28 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 06 Day
Date of IRB
2018 Year 08 Month 06 Day
Anticipated trial start date
2018 Year 08 Month 06 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In progress

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038635

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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