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

Not Applicable

Completed

• Conditions: Hypertriglyceridemia With the Metabolic Syndrome

• Registration Number: NCT00422396
• Lead Sponsor: University of Michigan

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, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

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.

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-04
• Study Completion: 2002-04
• Study First Submitted: 2007-01-12
• Study First Submitted QC: 2007-01-12
• Study First Posted: 2007-01-17
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
1. lipids and lipoproteins

Trial Locations

Locations (1)

Northwestern University preventive Cardiology Center; 🇺🇸 Chicago, Illinois, United States