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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2002-04-30

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.

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Detailed Description

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

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

Conditions

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Hypertriglyceridemia With the Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Fenofibrate (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. 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

1. included types 1 or 2 diabetes
2. Body mass index \>40 kg/m2
3. Use of lipid-lowering therapies
4. Oral hypoglycemic therapies
5. Insulin
6. Aspirin \>81 mg daily
7. 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)
8. Alcohol intake \>3 drinks per day
9. Untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy
10. Cigarette smoking (current or within the last 6 months)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes