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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422396
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia With the Metabolic Syndrome Drug: Fenofibrate (drug) Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Actual Study Start Date : January 2001
Actual Primary Completion Date : April 2002
Actual Study Completion Date : April 2002

Primary Outcome Measures :
  1. 1. lipids and lipoproteins

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422396

United States, Illinois
Northwestern University preventive Cardiology Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Michigan
Principal Investigator: Robert S Rosenson, MD University of Michigan

Responsible Party: University of Michigan Identifier: NCT00422396     History of Changes
Other Study ID Numbers: 877-017
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by University of Michigan:
Metabolic syndrome

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents