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



Status:Completed
Conditions:Cardiology, Endocrine, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:2/11/2017
Start Date:January 2001
End Date:April 2002

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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.

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.

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)
We found this trial at
1
site
680 North Lake Shore Drive
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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