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

Hypertriglyceridemia With the Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422396
• Other study ID #: 877-017
• Status: Completed
• Phase: N/A
• First received: January 12, 2007
• Last updated: February 9, 2017
• Start date: January 2001
• Est. completion date: April 2002

Study information

• Verified date: February 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Hypertriglyceridemia With the Metabolic Syndrome
• Metabolic Syndrome X
• Thrombosis

Intervention

Drug:
• Fenofibrate (drug)

Locations

Country	Name	City	State
United States	Northwestern University preventive Cardiology Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. lipids and lipoproteins