Status:
COMPLETED
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Abbott
Conditions:
Hypertriglyceridemia With the Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, in...
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 postp...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2002
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00422396
Start Date
January 1 2001
End Date
April 1 2002
Last Update
February 10 2017
Active Locations (1)
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1
Northwestern University preventive Cardiology Center
Chicago, Illinois, United States, 60611