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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003369
Receipt No. R000004096
Scientific Title Relationship between Doing and Laboratory Data of Diet and Exercise Therapy in Diabetic Patient
Date of disclosure of the study information 2010/03/24
Last modified on 2011/12/27

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Basic information
Public title Relationship between Doing and Laboratory Data of Diet and Exercise Therapy in Diabetic Patient
Acronym Relationship between Doing and Laboratory Data of Diet and Exercise Therapy
Scientific Title Relationship between Doing and Laboratory Data of Diet and Exercise Therapy in Diabetic Patient
Scientific Title:Acronym Relationship between Doing and Laboratory Data of Diet and Exercise Therapy
Region
Japan

Condition
Condition diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We research relationship between doing and laboratory data of diet and exercise therapy in type 2 diabetes mellitus by pharmacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We analyze laboratory data and drug being taken at before and after diet and exercise therapy.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 diet and exercise therapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria * Patient of type 2 diabetes mellitus was given instructions to diet and exercise therapy by doctor.
* Patient is taking medicine over the six months.
* Patient carry a medication notebook of diabetes mellitus.
* Patient take no lipid-lowering agent.
Key exclusion criteria Under 20 years.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu UNO
Organization Chiba Pharmaceutical Association
Division name Information Committee
Zip code
Address 7-1 Chibaminato, Chuo-ku, Chiba-shi, Chiba 260-0026, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba Pharmaceutical Association
Division name Drug Information Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Hironobu UNO
Institute
Department

Funding Source
Organization Chiba Pharmaceutical Association
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 24 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 03 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 24 Day
Last modified on
2011 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004096

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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