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Pharmacological Regulation of Fat Transport in Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632840
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : March 11, 2008
National Heart Foundation, Australia
Information provided by:
The University of Western Australia

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Lipid Disorders Hypertriglyceridemia Cardiovascular Disease Drug: Atorvastatin and fenofibrate Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
Study Start Date : June 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: P
placebo group
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra

Active Comparator: Feno
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra

Active Comparator: ATV
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra

Primary Outcome Measures :
  1. VLDL-apoC-III transport rate [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

any three of the followings

  • waist circumference >102cm
  • triglycerides >1.7 mmol/L
  • HDL-cholesterol <1.05 mmol/L
  • blood glucose >6.1 mmol/L
  • blood pressure >130/85mmHg

Exclusion Criteria:

  • plasma cholesterol >7mmo/L
  • triglycerides >4.5mmo/L
  • diabetes mellitus (defined by oral glucose tolerance test)
  • CVD
  • consumption of >30g alcohol/day
  • use of agents affecting lipid metabolism
  • APOE2/E2 genotype, macroproteinuria
  • creatinaemia (>120umol/L)
  • hypothyroidism
  • abnormal liver and muscle enzymes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00632840

Sponsors and Collaborators
The University of Western Australia
National Heart Foundation, Australia
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Principal Investigator: Dick C Chan, PhD The University of Western Australia

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gerald F Watts, University of Western Australia Identifier: NCT00632840     History of Changes
Other Study ID Numbers: UWA_DC012008
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: March 11, 2008
Last Verified: February 2008
Additional relevant MeSH terms:
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Metabolic Syndrome
Lipid Metabolism Disorders
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors