UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023010 |
|---|---|
| Receipt number | 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 14:45:30 |
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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
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
hhamasaki78@gmail.com
Sponsor or person
Institute
Department of Internal Medicine, National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023218
