Status:
UNKNOWN
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Pfizer
National Institutes of Health (NIH)
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (prim...
Detailed Description
This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NC...
Eligibility Criteria
Inclusion
- Adults with Metabolic Syndrome (meets 3 of the following 5)
- Abdominal obesity, waist circumference in men greater than 40 in. \& in women greater than 35 in.
- Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
- Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
- Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
- Fasting plasma glucose greater than 100 mg/dL
Exclusion
- Diabetes
- Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
- Angina or other chest pain that may indicate CHD
- Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
- Known abnormal LFTS greater than 2X ULN
- Smoker, illicit drug use, or excessive alcohol use
- Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
- Pregnancy or planning pregnancy during the study period
- Sensitivity or allergy to fish
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00350194
Start Date
October 1 2006
End Date
June 1 2012
Last Update
March 2 2012
Active Locations (1)
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1
Northwest Lipid Research Clinic (University of Washington Affiliated)
Seattle, Washington, United States, 98104