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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00422396
First received: January 12, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 12, 2007
January 12, 2007
January 2001
Not Provided
1. lipids and lipoproteins
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
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Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertriglyceridemia With the Metabolic Syndrome
Drug: Fenofibrate (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2002
Not Provided

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422396
877-017
Not Provided
Not Provided
University of Michigan
Abbott
Principal Investigator: Robert S Rosenson, MD University of Michigan
University of Michigan
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP