Metabolic Syndrome X
Conditions
Keywords
Fatty Acids, Omega-3
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acids
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
Sponsors
Pfizer
National Institutes of Health (NIH)
Northwest Lipid Research Clinic
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Carotid IMT | 1 year, 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Lipid (apolipoproteins and lipid parameters) | 1 year, 2 years |
| hs-CRP & SAA | 1 year, 2 years |
| Glucose | 1 year, 2 years |
| Insulin | 1 year, 2 years |
| adiponectin | 1 year, 2 years |
| urine microalbumin/creatinine | 1 year, 2 years |
| Serum Fatty Acids | 1 year, 2 years |
Countries
United States
Outcome results
None listed