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OpenTrials
Completed

NCT Number: NCT00422396

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University preventive Cardiology Center

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (between 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)

Treatment and study plan

Fenofibrate (drug)

Drug

Primary outcomes

  1. 1. lipids and lipoproteins

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Jan 17, 2007
Registry last updated
Feb 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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