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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014