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.
- Conditions
- Type 2 diabetes mellitus with hyperlipidemia
- Registration Number
- JPRN-UMIN000013776
- Lead Sponsor
- Chiba University Hospital, Division of Diabetes, Metabolism and Endocrinology
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of parameters in LDL particle size (for 12 weeks with administration of EPA/DHA)
- Secondary Outcome Measures
Name Time Method The change of - LDL particle concentration - LDL particle number - Cholesterol and triglyceride concentration, free glycerol concentration - Other cholesterol and triglyceride particle sizes - Other cholesterol and triglyceride particle concentration - Other cholesterol and triglyceride particle number - Lipoprotein Insulin Resistance Score (LPIR) - Inflammation Marker (GlycA) - EPA/AA ratio, DHA/AA ratio - Lipid profile (LDL-C, HDL-C, TG, etc) - HbA1c - Fasting blood glucose - Safety assessment (Renal function, Liver function, etc)