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
Recruitment status was Not yet recruiting
Sponsor:
Provident Clinical Research
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
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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: prescription omega-3 acid ethyl esters 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:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 22 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: prescription omega-3 acid ethyl esters
POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
|
Drug: prescription omega-3 acid ethyl esters
4g/day
Other Names:
|
|
Placebo Comparator: Placebo
Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
|
Drug: Placebo
matching placebo capsule, 4g/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 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.
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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034540
Contacts
| Contact: Kevin C. Maki, PhD | 630-858-4400 | kmaki@providentcrc.com |
Locations
| United States, Illinois | |
| Provident Clinical Research | Not yet recruiting |
| Addison, Illinois, United States, 60101 | |
| Contact: John Marshall, RN, BSN 630-617-2000 research@providentcrc.com | |
| Principal Investigator: Kevin C. Maki, PhD | |
Sponsors and Collaborators
Provident Clinical Research
GlaxoSmithKline
Investigators
| Study Director: | Kevin C. Maki, PhD | Provident Clinical Research |
More Information
No publications provided by Provident Clinical Research
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kevin C. Maki, PhD, President/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 |
| Last Updated: | January 26, 2010 |
| 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 May 23, 2013