UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017071 |
|---|---|
| Receipt number | 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 19:51:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Department of medicine II Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019327
