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

Primary Purpose

Hypertriglyceridemia With the Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate (drug)
Sponsored by
University of Michigan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia With the Metabolic Syndrome focused on measuring Hypertrigliceridemia, Metabolic syndrome, Obesity, Fenofibrate, Lipoproteins, Cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Northwestern University preventive Cardiology Center

Outcomes

Primary Outcome Measures

1. lipids and lipoproteins

Secondary Outcome Measures

Full Information

First Posted
January 12, 2007
Last Updated
February 9, 2017
Sponsor
University of Michigan
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00422396
Brief Title
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Official Title
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2001 (Actual)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
April 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan
Collaborators
Abbott

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia With the Metabolic Syndrome
Keywords
Hypertrigliceridemia, Metabolic syndrome, Obesity, Fenofibrate, Lipoproteins, Cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fenofibrate (drug)
Primary Outcome Measure Information:
Title
1. lipids and lipoproteins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Rosenson, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University preventive Cardiology Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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