N/A
N=23
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT01034540 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). — 3.2; 3.3 Index value — p=0.959
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- POM3 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Provident Clinical Research
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). |
3.2; 3.3 | 0.959 |
| SECONDARY Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. |
2.4; 2.1; 0.73; 0.66 | 0.037 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01034540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.