The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients
Recruitment status was Recruiting
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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 |
- Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis [ Time Frame: April 2009 ] [ Designated as safety issue: No ]
- 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 |
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| 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 |
| 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 | |
| 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 Hyperlipidemias Hypertriglyceridemia |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Dyslipidemias Lipid Metabolism Disorders |
ClinicalTrials.gov processed this record on May 16, 2013