UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038004 |
|---|---|
| Receipt number | R000040427 |
| Scientific Title | Shiga prevention of frailty and health behavior for diabetic outpatient follow-up study |
| Date of disclosure of the study information | 2019/09/24 |
| Last modified on | 2020/03/16 16:00:19 |
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Basic information
Public title
Shiga prevention of frailty and health behavior for diabetic
outpatient follow-up study
Acronym
Shiga prevention of frailty and health behavior for diabetic
outpatient follow-up study
Scientific Title
Shiga prevention of frailty and health behavior for diabetic
outpatient follow-up study
Scientific Title:Acronym
Shiga prevention of frailty and health behavior for diabetic
outpatient follow-up study
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe 5-year and 10-year changes of physical and cognitive functions, and to extract some factors of prevention or promotion of frailty in diabetic outpatient
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
physical function and cognitive function
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants of baseline study at Shiga university of medical science hospital in 2013
Key exclusion criteria
Nothing
Target sample size
485
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Ogita |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Division of Geriatric Nursing
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2390
tan3434@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Katayose |
Organization
Shiga University of Medical Science
Division name
Department of Clinical Nursing, Division of Geriatric Nursing
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
077-548-2392
Homepage URL
katayose@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Department of Clinical Nursing, Division of Geriatric Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga University of Medical Science
Department of Medicine, Division of Diabetes and Nephrology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.ac.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
| 2019 | Year | 09 | Month | 24 | 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
299
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate blood pressure, stabilometry, hand grip strength, knee extensor strength, bioelectrical impedance analysis, walking speed, cognitive function.
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040427
