Clinical trial NCT00422396: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia With the Metabolic Syndrome
Keywords: Hypertrigliceridemia
Metabolic syndrome
Obesity
Fenofibrate
Lipoproteins
Cytokines
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2007-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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 (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)

Primary outcomes:
measure: 1. lipids and lipoproteins
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University preventive Cardiology Center
state: Illinois
Study officials:
affiliation: University of Michigan
name: Robert S Rosenson, MD
role: PRINCIPAL_INVESTIGATOR
References: