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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034540
First Posted: December 17, 2009
Last Update Posted: October 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kevin C. Maki, PhD, Provident Clinical Research
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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 Kevin C. Maki, PhD, 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) ]
    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) ]

    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

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

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: May 28, 2013
Results First Posted: October 22, 2013
Last Update Posted: October 22, 2013
Last Verified: August 2013

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