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Completed

NCT Number: NCT00632840

Pharmacological Regulation of Fat Transport in Metabolic Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin and fenofibrate

Drug

atorvastatin (40mg/day) fenofibrate (200mg/day)

Other names: Lipitor, Lofibra

Primary outcomes

  1. VLDL-apoC-III transport rate

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Collaborators

  • National Heart Foundation, Australia

Registry information

Official study title

Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome

Important dates

Study start
2001
Primary completion
2002
Study completion
2007
First posted
Mar 11, 2008
Registry last updated
Mar 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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