Unique ID issued by UMIN | UMIN000031673 |
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Receipt number | 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 21:25:36 |
Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Effects of ethyl icosapentate and omega-3-acid ethyl esters on carotid intima-media thickness (IMT) in Japanese type 2 diabetes patients with dislipidemia
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Comparing the two groups of change in mean IMT over 12 months treatment period.
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)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
ethyl icosapentate 1.8g/day, 12 months
omega-3-acid ethyl ester 2g/day, 12 months
20 | years-old | <= |
Not applicable |
Male and Female
Japanese type2 diabetes patients with hypertriglyceridemia(over 150mg/dl)
(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.
120
1st name | |
Middle name | |
Last name | Yasuo Terauchi |
Yokohama City University Graduate School of Medicine
Department of Endocrinology and Metabolism
3-9 Fukuura, Kanazawa-ku, Yokohama
045-787-2800
terauchi@yokohama-cu.ac.jp
1st name | |
Middle name | |
Last name | Mayu Kyohara |
Yokohama City University Graduate School of Medicine
Department of Endocrinology and Metabolism
3-9 Fukuura, Kanazawa-ku, Yokohama
045-787-2800
kyouhara-tym@umin.ac.jp
Yokohama City University
None
Self funding
Japan Community Health care Organization,Yokohama Central Hospital
NO
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)
2018 | Year | 03 | Month | 13 | Day |
Unpublished
Open public recruiting
2018 | Year | 02 | Month | 15 | Day |
2018 | Year | 03 | Month | 09 | Day |
2018 | Year | 03 | Month | 11 | Day |
2018 | Year | 03 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036177
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