Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
This study has been completed.
Sponsor:
University of Michigan
Collaborator:
Abbott
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00422396
First received: January 12, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertriglyceridemia With the Metabolic Syndrome |
Drug: Fenofibrate (drug) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis |
Resource links provided by NLM:
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- 1. lipids and lipoproteins
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | April 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 (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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422396
Locations
| United States, Illinois | |
| Northwestern University preventive Cardiology Center | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
University of Michigan
Abbott
Investigators
| Principal Investigator: | Robert S Rosenson, MD | University of Michigan |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00422396 History of Changes |
| Other Study ID Numbers: | 877-017 |
| Study First Received: | January 12, 2007 |
| Last Updated: | January 12, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Hypertrigliceridemia Metabolic syndrome Obesity |
Fenofibrate Lipoproteins Cytokines |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Thrombosis Metabolic Syndrome X Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Fenofibrate Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013