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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kevin C. Maki, PhD, Provident Clinical Research
ClinicalTrials.gov Identifier:
NCT01034540
First received: December 16, 2009
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hypertriglyceridemia
Drug: POM3
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Provident Clinical Research:

Primary Outcome Measures:
  • Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI). [ Time Frame: End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index. [ Time Frame: End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14) ] [ Designated as safety issue: No ]

    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



Enrollment: 23
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POM3
POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
Drug: POM3
4 g/day
Other Names:
  • Lovaza
  • prescription omega-3 acid ethyl esters
Placebo Comparator: Placebo
Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
Drug: Placebo
matching placebo capsule, 4 g/day
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034540

Locations
United States, Illinois
Provident Clinical Research (now Biofortis)
Addison, Illinois, United States, 60101
Sponsors and Collaborators
Provident Clinical Research
GlaxoSmithKline
Investigators
Study Director: Kevin C. Maki, PhD Provident Clinical Research
  More Information

Publications:
Responsible Party: Kevin C. Maki, PhD, Study Director/Chief Science Officer, Provident Clinical Research
ClinicalTrials.gov Identifier: NCT01034540     History of Changes
Other Study ID Numbers: PRV-09009
Study First Received: December 16, 2009
Results First Received: May 28, 2013
Last Updated: August 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014