The subjects with hyper-triglyceridemia and atherosclerosis.
Conditions
Interventions
For study participants, 2 g once a day as omega-3 fatty acid ethylate, Lotriga, is administered in the morning immediately after meals.
Sponsors
Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-Renal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria The subjects who are following criteria are enrolled for the study; age >20 years old, subjects with hyper-triglyceridemia and fasting triglyceride >150mg/dl, subjects with ischemic heart disease (IHD) under current treatment or with history of IHD or subjects with cervical atherosclerosis (ccIMT>1.1mm) or subjects with PAD defined as ABI<0.9, subjects who agree with informed consent by practitioner at enrollment.
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: 1. Patients in whom Lotriga is contraindicated such as patients with a history of hypersensitivity to any ingredient of Lotriga or other omega-3 unsaturated fat, and patients who are bleeding with following conditions; hemophilia, capillary fragility disease, gastrointestinal ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc. 2. Patients with active infection or malignancies 3. Pregnant women, lactating women, and patients who wish to become pregnant 4. Patients who have not provided consent to participate in the study 5. Subjects with active inflammatory diseases or active malignant tumor. 6. Subjects who are already given other omega-3 unsaturated fat regimen. 7. Subjects who are already given other anti-hypertriglyceride medication such as fibrate derivatives, nicotinic acids derivatives. (Subjects who are already given statins are not excluded from participants.) 8. Subjects who are not in consent with research protocol. Furthermore, patients who meet the following criteria will be excluded: 1. Patients with symptomatic heart failure (NYHA class 2 or higher or EF < 40%) 2. Patients with possible type 1 diabetes mellitus 3. Patients who are scheduled to undergo coronary revascularization (Patients who underwent percutaneous transluminal coronary angioplasty including drug-eluting stent placement may be enrolled.) 4. Patients with serious liver or renal disorder 5. Patients who are determined to be not suitable by the investigator for reasons other than the above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: Changes of serum TG(triglyceride) concentrations, fatty acids four fractions before, during, and after clinical trials as for indexes of pharmaceutical efficacy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: Changes of fecal commensal microbiota. (T-RFLP), fecal IgA, fecal mucin for feces. Changes of serum auto-antibodies (anti-IL5), total IgG, IgG3. Changes of gene expressions of peripheral mononuclear cells. (RT-PCR) Changes of structural, functional markers for atherosclerosis. (cervical US, API/AVI). Occurrences of major adverse cardiovascular events. (MACE) | — |
Countries
Japan
Contacts
Public ContactKentaro Arakawa
Yokohama City University Hospital Laboratory Medicine
Outcome results
None listed