The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients
NCT ID: NCT00758927
Last Updated: 2009-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2009-07-31
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2
Placebo administration for 10 weeks with exercise and diet therapy
Placebo control
Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
1
Omacor 4 gram per day with exercise and diet therapy for 10 weeks
Omega-3 acid 4 grams per day
OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
Interventions
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Omega-3 acid 4 grams per day
OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
Placebo control
Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
40 Years
70 Years
ALL
No
Sponsors
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Kuhnil Pharmaceutical Co., Ltd.
INDUSTRY
Inje University
OTHER
Responsible Party
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Pusan Paik Hospital, Inje University
Principal Investigators
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Jeong H Park, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University
Locations
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Dong-A University Medical Center
Busan, , South Korea
Paik Diabetes Center
Busan, , South Korea
Endocrinology and Metabolism, Maryknoll General Hospital
Busan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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08-OM-9408
Identifier Type: -
Identifier Source: org_study_id
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