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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031673
Receipt No. R000036177
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
Date of disclosure of the study information 2018/03/13
Last modified on 2018/03/11

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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


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