UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011169 |
|---|---|
| Receipt number | R000013082 |
| Scientific Title | Effect of EPA/DHA supplementation added on DPP4 inhibitors on lipid and glucose metabolism in patients with type 2 diabetes |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2015/04/21 15:05:41 |
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Basic information
Public title
Effect of EPA/DHA supplementation added on DPP4 inhibitors on lipid and glucose metabolism in patients with type 2 diabetes
Acronym
Effect of EPA/DHA supplementation added on DPP4 inhibitors on lipid and glucose metabolism
Scientific Title
Effect of EPA/DHA supplementation added on DPP4 inhibitors on lipid and glucose metabolism in patients with type 2 diabetes
Scientific Title:Acronym
Effect of EPA/DHA supplementation added on DPP4 inhibitors on lipid and glucose metabolism
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of EPA/DHA supplementation on lipid and glucose metabolism in patients with type 2 diabetes who are treated with DPP4 inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c , GA , 1,5-AG, TC , TG, LDL-C, HDL-C and FFA
Key secondary outcomes
change in adiponectin, fasting plasma glucose, albuminuria, CRP, proinsulin, insulin, free fatty acid, fatty acid composition, and vascular endothelium function
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
| Medicine |
Interventions/Control_1
treatment with EPA / DHA supplementation (LOTRIGA ®) for 6 months
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
1) patients with type 2 diabetes
2) age 20 years or older
3) treated with DPP4 inhibitor
4) HbA1c >=6.9%
5) TG >=150mg/dl and/or HDL-C <40mg/dl
6) agreed to participate the study
Key exclusion criteria
1) Patients with a history of hypersensitivity to omega-3 fatty acids ethyl
2) Patients who are bleeding (Hemophilia, capillary fragility, gastrointestinal ulcers, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
3) Patients with severe ketosis or diabetic coma/pre-coma
4) Patients with severe infection, trauma or perioperative period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-5363-3797
ysaisho@z5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Saisho |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-5363-3797
Homepage URL
ysaisho@z5.keio.jp
Sponsor or person
Institute
Department of Internal Medicine,
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 01 | 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
| 2013 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 11 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013082
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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