The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients
The Effects of OMACOR on the LDL Sub-fraction in Korean Type 2 Diabetic Patients With Combined Hyperlipidemia
1 other identifier
interventional
70
1 country
3
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, we perform open-label prospective randomized multi-institutional phase IV study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
Started Jul 2009
Shorter than P25 for phase_4 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedAugust 6, 2009
August 1, 2009
9 months
September 23, 2008
August 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
April 2009
Secondary Outcomes (1)
The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
April 2009
Study Arms (2)
2
PLACEBO COMPARATORPlacebo administration for 10 weeks with exercise and diet therapy
1
EXPERIMENTALOmacor 4 gram per day with exercise and diet therapy for 10 weeks
Interventions
OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
- Kuhnil Pharmaceutical Co., Ltd.collaborator
Study Sites (3)
Dong-A University Medical Center
Busan, 602-715, South Korea
Paik Diabetes Center
Busan, 614-735, South Korea
Endocrinology and Metabolism, Maryknoll General Hospital
Busan, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong H Park, M.D., Ph.D.
Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 23, 2008
First Posted
September 25, 2008
Study Start
July 1, 2009
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
August 6, 2009
Record last verified: 2009-08