UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034500 |
|---|---|
| Receipt number | 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 | 2024/04/19 09:35:51 |
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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
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
kenizumi@kouhoukai.org
Sponsor or person
Institute
Takagi Hospital
Institute
Department
Personal name
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
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
https://takagi.kouhoukai.or.jp/about/ethics
Publication of results
Unpublished
Result
URL related to results and publications
Unpublishied
Number of participants that the trial has enrolled
80
Results
Currently being analyzed
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
average age 62
Participant flow
Those who agreed to participate while visiting our hospital.
Adverse events
nothing
Outcome measures
diabetic condition
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
| 2023 | 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
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038635
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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