Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors. - Effect of EPA/DHA combination therapy on LDL particle size

Chiba University Hospital, Division of Diabetes, Metabolism and Endocrinology0 个研究点目标入组 20 人开始时间: 2014年4月21日最近更新: 2023年11月20日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Concentrations of total cholesterol (P<0.001), LDL-C (P= 0.003), and triglyceride (P<0.001) decreased following n-3 PUFA administration. N-3 PUFAs decreased the size of very low-density lipoprotein (VLDL; P<0.001) particles, but did not affect LDL or high-density lipoprotein (HDL) particles. The concentration of large LDL increased, whereas small LDL decreased, causing the large to small LDL ratio to increase significantly (P=0.042). Large VLDL and chylomicron concentrations significantly decreased, as did the large to small VLDL ratio (all P<0.001). FPG levels unchanged, whereas HbA1c levels slightly increased. LPIR scores improved significantly (P= 0.001).

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: All

入选标准

未提供

排除标准

•Among the patients, those who judged as the criteria below are not eligible for the trial. 1) TG>=1000mg/dl or HDL-C =<30mg/dl 2) Received Fibrates 3) Received Pioglitazone 4) 0mega-3 fatty acids contraindication status (Bleeding: Hemophilia, Peptic ulcer, etc) 5) Hypersensitive history to EPA formulation or EPA/DHA formulation 6) Familial combined hyper low-density lipoproteinaemia 7) Type 1 diabetes mellitus 8) Severe diabetic ketosis, diabetic coma or total coma within 6 months 9) Severe infectious disease, before or after surgery, and sever trauma 10) Moderate renal dysfunction (Serum creatinine (mg/dl): male, 1.5=<; female, 1.3=<) 11) Occurrence of stroke, AMI, and the other severe cardiovascular events that lead patients to be hospitalized within 6 months 12) Concomitant malignant disease 13) Pregnant, lactating, possibly pregnant or planning to become pregnant women 14) Without written informed consent 15) Patients considered as inadequate by the principal investigator

研究者

发起方

Chiba University Hospital, Division of Diabetes, Metabolism and Endocrinology

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