The Effects of OMACOR on the LDL Sub-fraction in Korean Type 2 Diabetic Patients With Combined Hyperlipidemia
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
研究概览
简要总结
The purpose of this study is to verify the possible effects of OMACOR(omega-3 fatty acid) on the percentage change of small dense LDL fraction in type 2 diabetic patients with combined hyperlipidemia, we perform open-label prospective randomized multi-institutional phase IV study.
详细描述
The main cause of mortality in type 2 diabetes mellitus is a cardiovascular disease. Among the many risk factors of atherosclerosis in diabetic patients, LDL(low density lipoprotein) cholesterol is now being regarded as one of the most important modifiable one. Recent researches have revealed that the plasma LDL could be sub-divided according to the size of the particles into large buoyant LDL and small dense LDL. Small dense LDL is very atherogenic. Increased plasma triglyceride and the presence of insulin resistance are proved to be positively correlated well with the amount of small dense LDL in diabetic patients.
We would like to see omega-3 acid(OMACOR) which is now widely used in clinical practice to decrease plasma triglyceride could change the amount of plasma small dense LDL in type 2 diabetic patients with combined hyperlipidemia.
This trial is consisted of 6 weeks of wash out for the patients already taking statin. After that, daily 4 grams of omega-3 acid(OMACOR) will be administered for 10 weeks. Before and after the administration of study drug, we will measure the change of the amount of plasma small dense LDL via ultracentrifuge/non-denaturing polyacrylamide gel electrophoresis followed by oil red O and coomassie blue staining. As a secondary outcome measure, we will also assess the change of HDL(high density lipoprotein) cholesterol sub-type by the same method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agreed for informed consent
- •Age between 40-70 years old
- •Type 2 diabetes mellitus
- •Combined hyperlipidemia
- •Serum triglyceride level between 200-500(mg/dl)
- •No sudden change of glucose lowering therapies during trial, anticipated
排除标准
- •Hypersensitivity to OMACOR(Omega-3 fatty acid)
- •Alcoholics
- •Pregnancy
- •Proliferative diabetic retinopathy
- •Patients already taking fibrates
- •Enrolled in other clinical trials during the recent 3 months
- •Severe ischemic heart disease, liver disease, neurological disease
- •AST/ALT level 2 folds above the normal reference level
- •Psychiatric disorder not adequately controlled
- •Serum creatinine over 2.0 (mg/dl)
- •Previous pancreatic surgery
- •Patients who can not maintain regular diet
研究组 & 干预措施
2
Placebo administration for 10 weeks with exercise and diet therapy
干预措施: Placebo control (Drug)
1
Omacor 4 gram per day with exercise and diet therapy for 10 weeks
干预措施: Omega-3 acid 4 grams per day (Drug)
结局指标
主要结局
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
时间窗: April 2009
次要结局
- The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis(April 2009)