Examinations for immune-biological mechanism of anti-atherosclerotic effects of omega 3 lipid formula, Lotriga, focusing on commensal microbe and serum auto-antibodies.
- Conditions
- The subjects with hyper-triglyceridemia and atherosclerosis.
- Registration Number
- JPRN-UMIN000032320
- Lead Sponsor
- Yokohama City University Graduate School of Medicine, Department of Medical Science and Cardio-Renal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 36
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)