The Effects of Omega-3 Fatty Acids on Metabolic Syndrome

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acids


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Omega-3 fatty acid vs. placebo comparator | Dietary Supplement: Omega-3 fatty acids<br>* Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)<br>* Other names: Fish Oil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Carotid IMT |  | 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatty Acids, Omega-3