UMIN-CTR Clinical Trial

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
Email	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
Email	takashi_schecter@sakura.med.toho-u.ac.jp

Sponsor
Institute	Toho University Sakura Medical Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013134