Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis - Full Text View

Sponsor:	University of Michigan
Collaborator:	Abbott
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00422396

Purpose

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.

Condition	Intervention
Hypertriglyceridemia With the Metabolic Syndrome	Drug: Fenofibrate (drug)

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides

Drug Information available for: Procetofen

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

1. lipids and lipoproteins

Estimated Enrollment:	60
Study Start Date:	January 2001
Estimated Study Completion Date:	April 2002

Detailed Description:

The aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on:

Fasting and postprandial lipids and lipoproteins after a standarized test meal.
Fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal.
Fasting and postprandial inflammatory mediators after a standarized test meal.
Fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal.
Fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 (6.1 mmol/L and <7.0 mmol/L).

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00422396

Locations

United States, Illinois
Northwestern University preventive Cardiology Center
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

University of Michigan

Abbott

Investigators

Principal Investigator:

Robert S Rosenson, MD

University of Michigan

More Information

No publications provided

Study ID Numbers:	877-017
Study First Received:	January 12, 2007
Last Updated:	January 12, 2007
ClinicalTrials.gov Identifier:	NCT00422396 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Michigan:

Hypertrigliceridemia
Metabolic syndrome
Obesity

Fenofibrate
Lipoproteins
Cytokines

Additional relevant MeSH terms:

Antimetabolites
Hypertriglyceridemia
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Procetofen

Pharmacologic Actions
Thrombosis
Embolism and Thrombosis
Therapeutic Uses
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on March 18, 2010