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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023010
Receipt No. R000023218
Scientific Title Associations of physical activity, muscle strength and body composition with mortality, cradiovascular events, and glucose and lipid metabolism
Date of disclosure of the study information 2016/08/31
Last modified on 2017/08/29

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Basic information
Public title Associations of physical activity, muscle strength and body composition with mortality, cradiovascular events, and glucose and lipid metabolism
Acronym Associations of physical activity, muscle strength and body composition with mortality, cradiovascula events, glucose and lipid metabolism
Scientific Title Associations of physical activity, muscle strength and body composition with mortality, cradiovascular events, and glucose and lipid metabolism
Scientific Title:Acronym Associations of physical activity, muscle strength and body composition with mortality, cradiovascula events, glucose and lipid metabolism
Region
Japan

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

Objectives
Narrative objectives1 To examine the association of muscle strength (handgrip strength) and physical activity with mortality, cardiovascular events, and hospitalization during the study period in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Mortality, cardiovascular disease, and hospitalization.
Key secondary outcomes Changes in glycemic control and lipid profile.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who receive the first medical examination at National Center for Global Health and Medicine Kohonodai Hospital
Type 2 diabetic patients
Age over 18 years
Key exclusion criteria Type 1 diabetic patients or subjects whose anti-GAD antibody is positive
Subjects with the impairment of activity of daily living such as cerebral infarction sequelae
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetaka Hamassaki
Organization National Center for Global Health and Medicine Kohnodai Hospital
Division name Department of Internal Medicine
Zip code
Address 1-7-1, Kohnodai, Chiba, Japan
TEL 0473723501
Email hhamasaki78@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidetaka Hamasaki
Organization National Center for Global Health and Medicine Kohnodai Hospital,
Division name Department of Internal Medicine
Zip code
Address 1-7-1, Kohnodai, Chiba, Japan
TEL 0473723501
Homepage URL
Email hhamasaki78@gmail.com

Sponsor
Institute Department of Internal Medicine, National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 国立国際医療研究センター国府台病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 31 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 16 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 28 Day

Other
Other related information Retrospective cohort study.

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2017 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023218

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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