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

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 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


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

Value
https://center6.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