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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Provident Clinical Research.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Provident Clinical Research
ClinicalTrials.gov Identifier:
NCT01034540
First received: December 16, 2009
Last updated: January 26, 2010
Last verified: January 2010
History of Changes

December 16, 2009
January 26, 2010
March 2010
December 2010   (final data collection date for primary outcome measure)
The primary outcome variable will be the difference between treatments in insulin sensitivity as determined by LMTT analysis. [ Time Frame: Week 6 and Week 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01034540 on ClinicalTrials.gov Archive Site
Secondary outcome variables will be the difference between treatments in the insulin secretion index and the disposition index as determined by LMTT analysis. [ Time Frame: Week 6 and Week 14 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
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

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.

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 prescription omega-3 acid ethyl esters for the first 6 week phase followed by the study product they did not receive during the first phase (prescription omega-3 acid ethyl esters or placebo) for the second 6 weeks.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: prescription omega-3 acid ethyl esters
    4g/day
    Other Names:
    • Lovaza
    • POM3
  • Drug: Placebo
    matching placebo capsule, 4g/day
    Other Name: Placebo
  • Experimental: prescription omega-3 acid ethyl esters
    POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
    Intervention: Drug: 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
    Intervention: Drug: Placebo
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 ?-cell response in subjects with primary hypertriglyceridemia. Prostaglandins Leukot Essent Fatty Acids. 2011 Sep-Oct;85(3-4):143-8. Epub 2011 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
22
February 2011
December 2010   (final data collection date for primary outcome measure)

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 EPA,DHA, or a combination of EPA and DHA
  • 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)
Both
18 Years to 79 Years
No
Contact: Kevin C. Maki, PhD 630-858-4400 kmaki@providentcrc.com
United States
 
NCT01034540
PRV-09009
No
Kevin C. Maki, PhD, President/Chief Science Officer, Provident Clinical Research
Provident Clinical Research
GlaxoSmithKline
Study Director: Kevin C. Maki, PhD Provident Clinical Research
Provident Clinical Research
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP