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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035859
Receipt No. R000031902
Scientific Title Investigation of factors affecting declining physical function of type 2 diabetic patients
Date of disclosure of the study information 2019/02/14
Last modified on 2019/02/12

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Basic information
Public title Investigation of factors affecting declining physical function of type 2 diabetic patients
Acronym Investigation of factors affecting declining physical function of type 2 diabetic patients
Scientific Title Investigation of factors affecting declining physical function of type 2 diabetic patients
Scientific Title:Acronym Investigation of factors affecting declining physical function of type 2 diabetic patients
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigated the association of HbA1c levels of type 2 diabetes mellitus patients with amount of physical activity and physical function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Isometric knee extension
June, Heisei 28 - October Heisei 29
Key secondary outcomes The short Japanese version of the International Physical Activity Questionnaire:IPAQ
grip strength
Short Physical Performance Battery:SPPB score
4 m walking speed
5 times sit to stand test
Michigan Neuropathy Screening Instrument:MNSI
age
sex
disease duration
body mass index:BMI
HbA1c
eGFR
neutral fat
HDL-C
LDL-C
diabetic retinopathy and nephropathy status
hypoglycemic agent use and insulin therapy status

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
50 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Type 2 diabetic patients visiting Niigata Rinko Hospital and Niigata Bandai Hospital for diabetes outpatient
Key exclusion criteria Patients who had difficulty in walking because of either locomotor disorders or central nervous disorders, patients with severe respiratory or circulatory disorders, patients with decreased cognitive function, patients who lacked measurement items, and patients who did not give their personal consent for participation, were all excluded as subjects.
Target sample size 109

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Shirai
Organization Niigata Rinko Hospital, Niigata, Japan
Division name Department of Rehabilitation
Zip code
Address Momoyama-cho 1-114-3, Higashi-ku, Niigata City
TEL 025-274-5331
Email shiraino9@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Shirai
Organization Niigata Rinko Hospital, Niigata, Japan
Division name Department of Rehabilitation
Zip code
Address Momoyama-cho 1-114-3, Higashi-ku, Niigata City 950-8725, Japan
TEL 025-274-5331
Homepage URL
Email shiraino9@gmail.com

Sponsor
Institute Niigata Rinko Hospital, Niigata, Japan
Institute
Department

Funding Source
Organization Niigata Rinko Hospital, Niigata, Japan
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 2806-51
Org. issuing International ID_1 Niigata Rinko Hospital, Niigata, Japan
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 02 Month 14 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 Completed
Date of protocol fixation
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information These results suggest the possibility that the strength of the lower limbs can be increased by orientating Type 2 diabetes patients who only come to the hospital for regular monitoring, to promote a higher level of physical activity; this can contribute to preventing a decline in physical functions.

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031902

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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