Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effects of OMACOR on the LDL Sub-fraction in Korean Type 2 Diabetic Patients With Combined Hyperlipidemia
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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