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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029304
Receipt No. R000033421
Scientific Title The efficacy of eicosapentaenoic acid on glucose variability for type 2 diabetes mellitus: randomized controlled trial
Date of disclosure of the study information 2017/09/27
Last modified on 2018/10/01

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Basic information
Public title The efficacy of eicosapentaenoic acid on glucose variability for type 2 diabetes mellitus: randomized controlled trial
Acronym Effect of eicosapentaenoic acid for glucose variability
Scientific Title The efficacy of eicosapentaenoic acid on glucose variability for type 2 diabetes mellitus: randomized controlled trial
Scientific Title:Acronym Effect of eicosapentaenoic acid for glucose variability
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation on the effect of eicosapentaenoic acid for glucose variability
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the extent of change in mean amplitude of glycemic excursions (MAGE)
Key secondary outcomes mean glucose level of 24 hours, glycated hemoglobin, fatty acid

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 oral administration of eicosapentaenoic acid (epadel S 900mg 2pac/day) during 8 weeks
Interventions/Control_2 patients received continuous glucose monitoring twice at pre-randomized and after 8 weeks from randomization
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Physician-diagnosed diabetes mellitus concomitant with hyperlipidemia
Key exclusion criteria 1)medical past history of allergic to the drug of eicosapentaenoic acid
2)impossible to perform the continuous glucose monitoring due to patient situations
3)treated with hemodialysis
4)treated with insulin
5)patients with pregnancy
6)patients with implantable mechanical device (e.g. permanent pacemaker implanted)
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Matsumura
Organization Kansai Medical University Medical Center
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 Medical Center
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 Kansai Medical University
Institute
Department

Funding Source
Organization 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
2017 Year 09 Month 27 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
2017 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
2018 Year 08 Month 31 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 27 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/04/07 UMIN.xlsx


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