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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertriglyceridemia With the Metabolic Syndrome

Intervention / Treatment
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* Drug: Fenofibrate (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: included types 1 or 2 diabetes Body mass index >40 kg/m2 Use of lipid-lowering therapies Oral hypoglycemic therapies Insulin 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fenofibrate (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. lipids and lipoproteins |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertrigliceridemia, Metabolic syndrome, Obesity, Fenofibrate, Lipoproteins, Cytokines