Diabetes Mellitus, Type 2Phase 4NCT00758927
The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients
A Phase 4 study testing Omega-3 acid 4 grams per day in people with Diabetes Mellitus, Type 2 and Hypercholesterolemia, run by Inje University at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- Omega-3 acid 4 grams per day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Dong-A University Medical Center
Busan, 602-715
Duk K Kim, M.D., Ph.D., 82-51-240-5030, dkkim@dau.ac.kr
- Recruiting
Paik Diabetes Center
Busan, 614-735
Jeong H Park, M.D., Ph.D., 82-51-890-6074, pjhdoc@chol.com
Sang H Byun, RN, CDE, MS, 82-51-890-6471, busanmed260@hanmail.net
- Recruiting
Endocrinology and Metabolism, Maryknoll General Hospital
Busan
Mikyung Kim, MD PhD, 82-10-4547-9288, kmkdoc@yahoo.co.kr
Mikyung Kim, MD PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Omega-3 acid 4 grams per day, Placebo control
- Keywords
- diabetes mellitus, combined hyperlipidemia, OMACOR, small dense LDL, HDL subfraction
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia, Hypertriglyceridemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 acid 4 grams per dayDrug
Also called OMACOR
OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy
Placebo controlDrug
Also called Placebo
Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Placebo administration for 10 weeks with exercise and diet therapy Receives: Drug: Placebo control |
| 1 | Experimental | Omacor 4 gram per day with exercise and diet therapy for 10 weeks Receives: Drug: Omega-3 acid 4 grams per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Measured: April 2009
Secondary outcomes (1)
The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Measured: April 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJul 2009
- Primary completionApr 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Kuhnil Pharmaceutical Co., Ltd.
- Investigators
- Jeong H Park, M.D., Ph.D., Principal investigator, Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758927
- Sponsor's protocol ID
- 08-OM-9408
- Status last verified
- Aug 2009
- First submitted
- 23 Sep 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of OMACOR on the LDL Sub-fraction in Korean Type 2 Diabetic Patients With Combined Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00758927
- Acronym / sponsor ID
- 08-OM-9408
- Keywords
- diabetes mellitus, combined hyperlipidemia, OMACOR, small dense LDL, HDL subfraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Kuhnil Pharmaceutical Co., Ltd.
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: Placebo controlPlacebo administration for 10 weeks with exercise and diet therapy |
| 1 | Experimental | Drug: Omega-3 acid 4 grams per dayOmacor 4 gram per day with exercise and diet therapy for 10 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agreed for informed consent
- Age between 40-70 years old
- Type 2 diabetes mellitus
- Combined hyperlipidemia
- Serum triglyceride level between 200-500(mg/dl)
Key exclusion criteria (12 listed)
- Hypersensitivity to OMACOR(Omega-3 fatty acid)
- Alcoholics
- Pregnancy
- Proliferative diabetic retinopathy
- Patients already taking fibrates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 acid 4 grams per dayAlso: OMACOROMACOR 4 grams per day is administered simultaneously with exercise and diet therapy | Drug | 1 |
| Placebo controlAlso: PlaceboPlacebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm | Drug | 2 |
Primary outcome
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Time frame: April 2009
1 secondary outcome
The percentage change of plasma HDL sub-fraction measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis
Time frame: April 2009
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong H Park, M.D., Ph.D. principal investigator
Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 acid 4 grams per day in people with Diabetes Mellitus, Type 2 and Hypercholesterolemia, run by Inje University at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong H Park, M.D., Ph.D. (82-51-890-6074, pjhdoc@chol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change of plasma small dense LDL measured by ultracentrifuge-non denaturing polyacrylamide gel electrophoresis (time frame: April 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.