Status:
UNKNOWN
The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients
Lead Sponsor:
Inje University
Collaborating Sponsors:
Kuhnil Pharmaceutical Co., Ltd.
Conditions:
Diabetes Mellitus, Type 2
Hypercholesterolemia
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
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,...
Detailed Description
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 no...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00758927
Start Date
July 1 2009
End Date
July 1 2010
Last Update
August 6 2009
Active Locations (3)
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1
Dong-A University Medical Center
Busan, South Korea, 602-715
2
Paik Diabetes Center
Busan, South Korea, 614-735
3
Endocrinology and Metabolism, Maryknoll General Hospital
Busan, South Korea