UMIN-CTR Clinical Trial

Basic information
Public title	Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Acronym	Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Scientific Title	Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Scientific Title:Acronym	Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the effects of ethyl icosapentate and omega-3-acid ethyl ester on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with hypertriglyceridemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing the two groups of change in mean IMT over 12 months treatment period.
Key secondary outcomes	Change in next items between baseline and 12 months of treatment. 1. Body weigh, BMI, Waist circumference 2. Systolic blood pressure, Diastolic blood pressure 3. Fasting plasma glucose 4. HbA1c 5. Serum insulin 6. C-peptide 7. HOMA-R 8. CPR-index 9. Total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, EPA/AA ratio 10. Urin protein, Urine albumin 11. high-sensitive CRP 12. Serum PAI-1 13. carotid max intima-media thickness (IMT) 14. PWV (Pulse wave velocity)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ethyl icosapentate 1.8g/day, 12 months
Interventions/Control_2	omega-3-acid ethyl ester 2g/day, 12 months
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	Japanese type2 diabetes patients with hypertriglyceridemia(over 150mg/dl)
Key exclusion criteria	(1) Patients already taking ethyl icosapentate or omega-3-acid ethyl ester (2) Patients who are bleeding (hemophilia, capillary vulnerability, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage etc) (3) Patients with allergy to ethyl icosapentate and omega-3-acid ethyl ester (4) Pregnancy or lactation in women (5) Patients with severe complications( liver disease, mental disorder, cancer) (6) Patients with severe ketosis or diabetic coma. (7) Patients with severe infections, perioperative status, or severe trauma (8) Patients whose written imformed consent was obtained. (9) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mayu Kyohara
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	kyouhara-tym@umin.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japan Community Health care Organization,Yokohama Central Hospital
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	横浜市立大学附属病院（神奈川県）Yokohama City University Hospital(kanagawa) 地域医療機能推進機構　横浜中央病院（神奈川県） Japan Community Health care Organization,Yokohama Central Hospital(kanagawa)

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 13 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 09 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	2018 Year 03 Month 11 Day
Last modified on	2018 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036177

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.