临床试验/NCT00422396

NCT00422396已完成不适用

Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis

University of Michigan2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2001年1月最近更新: 2017年2月10日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Michigan
入组人数: 60
试验地点: 2
主要终点: 1. lipids and lipoproteins

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

详细描述

The aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on:

Fasting and postprandial lipids and lipoproteins after a standarized test meal.
Fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal.
Fasting and postprandial inflammatory mediators after a standarized test meal.
Fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal.
Fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/L and <6.9 mmol/L
•two or more of the following Adult Treatment Panel III (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference >89 cm in females and >102 cm in males); low high-density lipoprotein cholesterol (HDL-C) (<1.3 mmol/L in women and <1.0 mmol/L in men); hypertension (systolic blood pressure >130 or diastolic blood pressure >85 mm Hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/L and 7.0 mmol/L).

排除标准

•included types 1 or 2 diabetes
•Body mass index >40 kg/m2
•Use of lipid-lowering therapies
•Oral hypoglycemic therapies
•Aspirin >81 mg daily
•Regular use of non-steroidal anti-inflammatory agents or cyclooxygenase-2 inhibitors, corticosteroids (oral and inhaled), anti-oxidants (including multivitamins), herbal or fiber supplements recent changes in type or formulation of hormone replacement therapy (in the last 6 months)
•Alcohol intake >3 drinks per day
•Untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy
•Cigarette smoking (current or within the last 6 months)

结局指标

主要结局

1. lipids and lipoproteins

次要结局

未报告次要终点

研究者

发起方

University of Michigan

申办方类型

Other

责任方

Sponsor

研究点 (2)

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