Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
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
1 other identifier
interventional
23
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
October 22, 2013
CompletedMay 30, 2024
May 1, 2024
9 months
December 16, 2009
May 28, 2013
May 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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)
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.
End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Study Arms (2)
POM3
EXPERIMENTALPOM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
Placebo
PLACEBO COMPARATORPlacebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Poorly controlled hypertension
- Certain medications
- Active cancers treated within prior 2 years (except non-melanoma skin cancer)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Provident Clinical Researchlead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Provident Clinical Research (now Biofortis)
Addison, Illinois, 60101, United States
Related Publications (1)
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.
PMID: 21775113RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Potential limitations: 1) relatively small sample size, and 2) relatively short length of wash-out period between treatments.
Results Point of Contact
- Title
- John Marshall, General Manager
- Organization
- Biofortis Clinical Research (formerly Provident)
Study Officials
- STUDY DIRECTOR
Kevin C. Maki, PhD
Provident Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Director/Chief Science Officer
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
March 1, 2010
Primary Completion
December 1, 2010
Study Completion
February 1, 2011
Last Updated
May 30, 2024
Results First Posted
October 22, 2013
Record last verified: 2024-05