Clinical trial NCT01034540: Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-12-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
timeFrame: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Secondary outcomes:
measure: Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.
timeFrame: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Other outcomes:
Locations:
city: Addison
country: United States
facility: Provident Clinical Research (now Biofortis)
state: Illinois
Study officials:
affiliation: Provident Clinical Research
name: Kevin C. Maki, PhD
role: STUDY_DIRECTOR
References:
citation: 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.