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| ID | Type | Description | Link |
|---|---|---|---|
| 05-8693-D 03 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
| Northwest Lipid Research Clinic | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Omega-3 fatty acid vs. placebo comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acids | Dietary Supplement | Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Carotid IMT | 1 year, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid (apolipoproteins and lipid parameters) | 1 year, 2 years | |
| hs-CRP & SAA | 1 year, 2 years | |
| Glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pathmaja Paramsothy, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Lipid Research Clinic (University of Washington Affiliated) | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |