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
  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
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:


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:

  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

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

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

Keywords provided by University of Michigan:
Hypertrigliceridemia
Metabolic syndrome
Obesity
Fenofibrate
Lipoproteins
Cytokines

Additional relevant MeSH terms:
Hypertriglyceridemia
Thrombosis
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014