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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Type 2 diabetes | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
terauchi@yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |