UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004003 |
|---|---|
| Receipt number | 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 10:22:12 |
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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
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
Sponsor or person
Institute
Graduate schoolof human and environmental studies, Kyoto university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004813
