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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004003
Receipt No. R000004813
Scientific Title The study of intervention with triaxial accelerometer in type 2 diabetes
Date of disclosure of the study information 2010/08/06
Last modified on 2011/09/11

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Basic information
Public title The study of intervention with triaxial accelerometer in type 2 diabetes
Acronym The study of exercise intervention in type 2 diabetes
Scientific Title The study of intervention with triaxial accelerometer in type 2 diabetes
Scientific Title:Acronym The study of exercise intervention in type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to investigate whether or not nonexercise activity improves glucose and lipid metabolism in type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fasting glucose concentration
HbA1c
Key secondary outcomes choresterol
triglyceride
body mass

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 patinets receive standard exercise counseling
Interventions/Control_2 patients receive standard exercise counselling and are ask to enhance the quantity of nonexercise activity
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria patinets with typw 2 diabetes
Key exclusion criteria smorker
patinets who are treated with beta blocker
patinets with arrhythmia
patients with sever diabetic comlications
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Moritani
Organization Graduate schoolof human and environmental studies, Kyoto university
Division name Laboratory of applied physiology
Zip code
Address Nihonmatsucho, Yosida, Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate schoolof human and environmental studies, Kyoto university
Division name Laboratory of applied physiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Graduate schoolof human and environmental studies, Kyoto university
Institute
Department

Funding Source
Organization japan society for the promotion science
Organization
Division
Category of Funding Organization
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 京都逓信病院

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 06 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
2010 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 05 Day
Last modified on
2011 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004813

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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