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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017071
Receipt No. R000019327
Scientific Title Effect of EPA for Diabetes mellitus
Date of disclosure of the study information 2015/04/08
Last modified on 2017/07/20

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Basic information
Public title Effect of EPA for Diabetes mellitus
Acronym Effect of EPA for Diabetes mellitus
Scientific Title Effect of EPA for Diabetes mellitus
Scientific Title:Acronym Effect of EPA for Diabetes mellitus
Region
Japan

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

Objectives
Narrative objectives1 Evaluate on the effect of EPA in patient with Diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Significant improvement of glucose fluctuation with continuous glucose monitoring
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 oral drug
Interventions/Control_2 continuous glucose monitoring
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 Physician-diagnosed diabetes mellitus concomitant with dyslipidemia
Key exclusion criteria There is medical past history of allergic to the eicosapentaenoic acid (EPA)
impossible to perform the continuous glucose monitoring due to patient situations
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Matsumura
Organization Kansai Medical University Takii Hospital
Division name Department of medicine II
Zip code
Address 10-15 Fumizono-cho Moriguchi city, Osaka
TEL 06-6992-1001
Email kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Matsumura
Organization Kansai Medical University Takii Hospital
Division name Department of medicine II
Zip code
Address 10-15 Fumizono-cho Moriguchi city, Osaka
TEL 06-6992-1001
Homepage URL
Email kmatsumura1980@yahoo.co.jp

Sponsor
Institute Department of medicine II Kansai Medical University
Institute
Department

Funding Source
Organization Department of medicine II Kansai Medical University
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

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 08 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 Terminated
Date of protocol fixation
2015 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 07 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 08 Day
Last modified on
2017 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019327

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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