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

February 9, 2017 updated by: University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University preventive Cardiology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1. lipids and lipoproteins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Abbott

Investigators

  • Principal Investigator: Robert S Rosenson, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2001

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

April 1, 2002

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 877-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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