Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Carotid IMT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Carotid IMT
时间窗: 1 year, 2 years
次要结局
- 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)
研究者
Pathmaja Paramsothy
Assistant Professor of Medicine
University of Washington