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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
University of Michigan
ClinicalTrials.gov Identifier:
NCT00422396
First received: January 12, 2007
Last updated: February 9, 2017
Last verified: February 2017

January 12, 2007
February 9, 2017
January 2001
April 2002   (Final data collection date for primary outcome measure)
1. lipids and lipoproteins
Same as current
Complete list of historical versions of study NCT00422396 on ClinicalTrials.gov Archive Site
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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
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Hypertriglyceridemia With the Metabolic Syndrome
Drug: Fenofibrate (drug)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2002
April 2002   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00422396
877-017
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University of Michigan
University of Michigan
Abbott
Principal Investigator: Robert S Rosenson, MD University of Michigan
University of Michigan
February 2017

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