UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Associations of physical activity, muscle strength and body composition with mortality, cradiovascular events, and glucose and lipid metabolism
Title of the study (Brief title)	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	Hidetaka Hamassaki
Organization	National Center for Global Health and Medicine Kohnodai Hospital
Division name	Department of Internal Medicine
Address	1-7-1, Kohnodai, Chiba, Japan
TEL	0473723501
Email	hhamasaki78@gmail.com

Public contact
Name of contact person	Hidetaka Hamasaki
Organization	National Center for Global Health and Medicine Kohnodai Hospital,
Division name	Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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