UMIN-CTR Clinical Trial

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
Email	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
Email	katayose@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Department of Clinical Nursing, Division of Geriatric Nursing
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040427