Clinical trial NCT00350194: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Official title: Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome X
Keywords: Fatty Acids, Omega-3
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Pfizer
name: National Institutes of Health (NIH)
name: Northwest Lipid Research Clinic
First posted: 2006-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.

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 NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Carotid IMT
timeFrame: 1 year, 2 years
Secondary outcomes:
measure: Lipid (apolipoproteins and lipid parameters)
timeFrame: 1 year, 2 years
measure: hs-CRP & SAA
timeFrame: 1 year, 2 years
measure: Glucose
timeFrame: 1 year, 2 years
measure: Insulin
timeFrame: 1 year, 2 years
measure: adiponectin
timeFrame: 1 year, 2 years
measure: urine microalbumin/creatinine
timeFrame: 1 year, 2 years
measure: Serum Fatty Acids
timeFrame: 1 year, 2 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Northwest Lipid Research Clinic (University of Washington Affiliated)
state: Washington
Study officials:
affiliation: University of Washington
name: Pathmaja Paramsothy, MD
role: PRINCIPAL_INVESTIGATOR
References: