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

NCT00422396 | Completed

• 1 other identifier: 877-017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia With the Metabolic Syndrome

Keywords

Hypertrigliceridemia; Metabolic syndrome; Obesity; Fenofibrate; Lipoproteins; Cytokines

Outcome Measures

Primary Outcomes (1)

• 1. lipids and lipoproteins

Interventions

Fenofibrate (drug) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Abbott: collaborator

Study Sites (1)

Northwestern University preventive Cardiology Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Interventions

Fenofibrate; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Robert S Rosenson, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2007
• First Posted: January 17, 2007
• Study Start: January 1, 2001
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (1)