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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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
Last updated: January 12, 2007

Page last updated: August 23, 2015

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