HypertriglyceridemiaNCT01034540
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
A study testing POM3 in people with Hypertriglyceridemia, run by Provident Clinical Research at 1 site in United States.
Trial summary
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- POM3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women, ages 18-79 years.
- Fasting, triglyceride (TG) level in the borderline high to high range.
- Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy
- Provide written informed consent and authorization for protected health information
Who cannot join
- Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy.
- Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with >1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA
- coronary heart disease (CHD) or a CHD risk equivalent
- Body mass index over 45 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug
- Certain muscle, liver, kidney, lung or gastrointestinal conditions
Show all 9Show fewer
- Poorly controlled hypertension
- Certain medications
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Provident Clinical Research (now Biofortis)
Addison, Illinois, 60101
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Acid Ethyl Esters on Indices of Glucose Homeostasis and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.
Read the detailed description
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.
- Conditions
- Hypertriglyceridemia
- Being tested
- POM3, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POM3Drug
Also called Lovaza, prescription omega-3 acid ethyl esters
4 g/day
PlaceboDrug
matching placebo capsule, 4 g/day
| Study group | Role | What they receive |
|---|---|---|
| POM3 | Experimental | POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment Receives: Drug: POM3 |
| Placebo | Placebo comparator | Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)
Measured: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Secondary outcomes (1)
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.
Insulin secretion index = total area under the curve from 0 to 120 min post-meal for plasma insulin divided by total area under the curve from 0 to 120 min post-meal for plasma glucose.
Disposition index = MISI x insulin secretion index
Measured: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertriglyceridemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provident Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Kevin C. Maki, PhD, Provident Clinical Research
- Investigators
- Kevin C. Maki, PhD, Study director, Provident Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034540
- Sponsor's protocol ID
- PRV-09009
- Status last verified
- May 2024
- First submitted
- 16 Dec 2009
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maki KC, Lawless AL, Kelley KM, Dicklin MR, Schild AL, Rains TM. Prescription omega-3-acid ethyl esters reduce fasting and postprandial triglycerides and modestly reduce pancreatic beta-cell response in subjects with primary hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2011 Sep-Oct;85(3-4):143-8. doi: 10.1016/j.plefa.2011.06.005. Epub 2011 Jul 19.
PubMed 21775113
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Acid Ethyl Esters on Indices of Glucose Homeostasis and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT01034540
- Acronym / sponsor ID
- PRV-09009
- Conditions
- Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Provident Clinical ResearchUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Posted 22 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.
Detailed description
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POM3 | Experimental | Drug: POM3POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for the first six weeks of treatment. POM3 for the second six weeks of treatment |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and postmenopausal women, ages 18-79 years.
- Fasting, triglyceride (TG) level in the borderline high to high range.
- Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy
- Provide written informed consent and authorization for protected health information
Key exclusion criteria (9 listed)
- Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy.
- Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with >1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA
- coronary heart disease (CHD) or a CHD risk equivalent
- Body mass index over 45 kg per square meter
- Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug
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 |
|---|---|---|
| POM3Also: Lovaza, prescription omega-3 acid ethyl esters4 g/day | Drug | POM3 |
| Placebomatching placebo capsule, 4 g/day | Drug | Placebo |
Primary outcome
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
Time frame: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)
1 secondary outcome
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.
Time frame: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21775113Maki KC, Lawless AL, Kelley KM, Dicklin MR, Schild AL, Rains TM. Prescription omega-3-acid ethyl esters reduce fasting and postprandial triglycerides and modestly reduce pancreatic beta-cell response in subjects with primary hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2011 Sep-Oct;85(3-4):143-8. doi: 10.1016/j.plefa.2011.06.005. Epub 2011 Jul 19.
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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.
Kevin C. Maki, PhD study director
Provident Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POM3 in people with Hypertriglyceridemia, run by Provident Clinical Research at 1 site in United States.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). (time frame: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01034540, which also lists 1 linked publication.
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 30 May 2024.