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Sponsors and Collaborators: |
The University of Western Australia National Heart Foundation |
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Information provided by: | The University of Western Australia |
ClinicalTrials.gov Identifier: | NCT00632840 |
The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.
Condition | Intervention | Phase |
---|---|---|
Obesity Lipid Disorders Hypertriglyceridemia Cardiovascular Disease |
Drug: Atorvastatin and fenofibrate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome |
Enrollment: | 11 |
Study Start Date: | June 2001 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P: Placebo Comparator
placebo group
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Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
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Feno: Active Comparator
Fenofibrate
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Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
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ATV: Active Comparator
Atorvastatin
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Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
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Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently predicts cardiovascular disease (CVD).
Hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs).
Although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the dysregulation of TRL metabolism.
investigating the effects of these agents on VLDL-apoC-III kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin and fenofibrate would have similar effects on apoC-III transport by decreasing the production and increasing the catabolism of VLDL-apoC-III.
Ages Eligible for Study: | 25 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
any three of the followings
Exclusion Criteria:
Responsible Party: | University of Western Australia ( Gerald F Watts ) |
Study ID Numbers: | UWA_DC012008 |
Study First Received: | February 20, 2008 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00632840 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Antimetabolites Obesity Hypertriglyceridemia Metabolic Diseases Hyperlipidemias Antilipemic Agents Overweight Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Procetofen Body Weight Signs and Symptoms Nutrition Disorders Overnutrition Metabolic Disorder Dyslipidemias Atorvastatin Lipid Metabolism Disorders |
Antimetabolites Obesity Hypertriglyceridemia Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Overweight Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Procetofen Pharmacologic Actions Body Weight Signs and Symptoms Therapeutic Uses Nutrition Disorders Cardiovascular Diseases Overnutrition Atorvastatin Dyslipidemias Lipid Metabolism Disorders |