UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011206 |
|---|---|
| Receipt number | R000013134 |
| Scientific Title | Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia |
| Date of disclosure of the study information | 2013/07/22 |
| Last modified on | 2021/10/05 08:25:32 |
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Basic information
Public title
Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Acronym
Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Scientific Title
Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Scientific Title:Acronym
Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Region
| Japan |
Condition
Condition
Hypertriglyceridemia with type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of combination therapy of EPA and DHA on arterial stiffness as well as on lipid metabolic factors in type 2 diabetic patients with hypertriglyceridemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A change in CAVI(cardio-ankle vascular index)
Key secondary outcomes
Changes in lipid metabolic parameters (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, apoprotein, LPL mass)
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
Switch from Epadel(1800mg/day) to rotoriga (2g/day) for 3 months.
If the triglyceride level in the blood does not meet the management standards, will be increased to 4g/day from 2g/day the dose of rotoriga.
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients in Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Medical Center with type 2 diabetes and hypertriglyceridemia, taking 1800mg/day of epadel.
Key exclusion criteria
Severe hypertriglyceridemia (TG>1000mg/dl)
Familial hypercholesterolemia
Patients with allergy to DHA
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yamaguchi |
Organization
Toho University Sakura Medical Cneter
Division name
Center of Diabetes, Endocrine and Metabolism
Zip code
Address
564-1, Shimoshizu, Sakura-City, Chiba, Japan
TEL
+81-43-462-8811
takashi_schecter@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yamaguchi |
Organization
Toho University Sakura Medical Cneter
Division name
Center of Diabetes, Endocrine and Metabolism
Zip code
Address
564-1, Shimoshizu, Sakura-City, Chiba, Japan
TEL
+81-43-462-8811
Homepage URL
takashi_schecter@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
| 2013 | Year | 07 | Month | 22 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 22 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013134
