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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POM3
Placebo
Sponsored by
Provident Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Provident Clinical Research (now Biofortis)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

POM3

Placebo

Arm Description

POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment

Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2009
Last Updated
August 14, 2013
Sponsor
Provident Clinical Research
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01034540
Brief Title
Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Provident Clinical Research
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
POM3
Arm Type
Experimental
Arm Description
POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
Intervention Type
Drug
Intervention Name(s)
POM3
Other Intervention Name(s)
Lovaza, prescription omega-3 acid ethyl esters
Intervention Description
4 g/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo capsule, 4 g/day
Primary Outcome Measure Information:
Title
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
Description
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)
Time Frame
End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)
Secondary Outcome Measure Information:
Title
Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.
Description
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
Time Frame
End of Treatment Intervention Phase I (week 6) and End of Treatment Intervention Period II (week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin C. Maki, PhD
Organizational Affiliation
Provident Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
Provident Clinical Research (now Biofortis)
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21775113
Citation
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. Prostaglandins Leukot Essent Fatty Acids. 2011 Sep-Oct;85(3-4):143-8. doi: 10.1016/j.plefa.2011.06.005. Epub 2011 Jul 19.
Results Reference
result

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

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