The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients

August 3, 2009 updated by: Inje University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeong H Park, M.D., Ph.D.
  • Phone Number: 82-51-890-6074
  • Email: pjhdoc@chol.com

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Recruiting
        • Dong-A University Medical Center
        • Contact:
          • Duk K Kim, M.D., Ph.D.
          • Phone Number: 82-51-240-5030
          • Email: dkkim@dau.ac.kr
      • Busan, Korea, Republic of, 614-735
        • Recruiting
        • Paik Diabetes Center
        • Contact:
          • Jeong H Park, M.D., Ph.D.
          • Phone Number: 82-51-890-6074
          • Email: pjhdoc@chol.com
        • Contact:
      • Busan, Korea, Republic of
        • Recruiting
        • Endocrinology and Metabolism, Maryknoll General Hospital
        • Contact:
        • Principal Investigator:
          • Mikyung Kim, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo administration for 10 weeks with exercise and diet therapy
Drug: Placebo control
Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
Other Names:
  • Placebo
Experimental: 1
Omacor 4 gram per day with exercise and diet therapy for 10 weeks
Drug: Omega-3 acid 4 grams per day
OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
Other Names:
  • OMACOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Time Frame: April 2009
April 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Time Frame: April 2009
April 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Collaborators

Kuhnil Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jeong H Park, M.D., Ph.D., Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-OM-9408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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