Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Information source: University of Michigan
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertriglyceridemia With the Metabolic Syndrome
Intervention: Fenofibrate (drug) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Robert S Rosenson, MD, Principal Investigator, Affiliation: University of Michigan
Summary
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.
Clinical Details
Official title: Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 1. lipids and lipoproteins
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 (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).
Locations and Contacts
Northwestern University preventive Cardiology Center, Chicago, Illinois 60611, United States
Additional Information
Starting date: January 2001
Ending date: April 2002
Last updated: January 12, 2007
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