Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034540
• Other study ID #: PRV-09009
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2024
• Source: Provident Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• POM3
4 g/day
• Placebo
matching placebo capsule, 4 g/day

Locations

Country	Name	City	State
United States	Provident Clinical Research (now Biofortis)	Addison	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Provident Clinical Research	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & 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. Prostagl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)