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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Inje University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kuhnil Pharmaceutical Co., Ltd.
Information provided by:
Inje University
ClinicalTrials.gov Identifier:
NCT00758927
First received: September 23, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Hypercholesterolemia
Hypertriglyceridemia
Drug: Omega-3 acid 4 grams per day
Drug: Placebo control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of OMACOR on the LDL Sub-fraction in Korean Type 2 Diabetic Patients With Combined Hyperlipidemia

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: OMACOR

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758927

Contacts
Contact: Jeong H Park, M.D., Ph.D. 82-51-890-6074 pjhdoc@chol.com
Contact: Mi K Kim, M.D., Ph.D. 82-10-4547-9288 kmkdoc@hanmail.net

Locations
Korea, Republic of
Paik Diabetes Center Recruiting
Busan, Korea, Republic of, 614-735
Contact: Jeong H Park, M.D., Ph.D.    82-51-890-6074    pjhdoc@chol.com   
Contact: Sang H Byun, RN, CDE, MS    82-51-890-6471    busanmed260@hanmail.net   
Endocrinology and Metabolism, Maryknoll General Hospital Recruiting
Busan, Korea, Republic of
Contact: Mikyung Kim, MD PhD    82-10-4547-9288    kmkdoc@yahoo.co.kr   
Principal Investigator: Mikyung Kim, MD PhD         
Dong-A University Medical Center Recruiting
Busan, Korea, Republic of, 602-715
Contact: Duk K Kim, M.D., Ph.D.    82-51-240-5030    dkkim@dau.ac.kr   
Sponsors and Collaborators
Inje University
Kuhnil Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Jeong H Park, M.D., Ph.D. Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University
  More Information

No publications provided

Responsible Party: Jeong Hyun Park/Professor, Pusan Paik Hospital, Inje University
ClinicalTrials.gov Identifier: NCT00758927     History of Changes
Other Study ID Numbers: 08-OM-9408
Study First Received: September 23, 2008
Last Updated: August 3, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
diabetes mellitus
combined hyperlipidemia
OMACOR
small dense LDL
HDL subfraction

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
Hypertriglyceridemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 15, 2014