Effects of Prescription Omega-3 Acids on Glucose and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
This study has been completed.
Information provided by (Responsible Party):
Kevin C. Maki, PhD, Provident Clinical Research
First received: December 16, 2009
Last updated: August 14, 2013
Last verified: August 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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
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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2010 (Final data collection date for primary outcome measure)
POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
- 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
matching placebo capsule, 4 g/day
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.
|Ages Eligible for Study:
||18 Years to 79 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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)
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
|Provident Clinical Research (now Biofortis)
|Addison, Illinois, United States, 60101 |
Provident Clinical Research
||Kevin C. Maki, PhD
||Provident Clinical Research
||Kevin C. Maki, PhD, Study Director/Chief Science Officer, Provident Clinical Research
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 16, 2009
|Results First Received:
||May 28, 2013
||August 14, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 23, 2016
Lipid Metabolism Disorders