Pharmacological Regulation of Fat Transport in Metabolic Syndrome

This study has been completed.
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by:
The University of Western Australia
ClinicalTrials.gov Identifier:
NCT00632840
First received: February 20, 2008
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • VLDL-apoC-III transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

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
Placebo Comparator: P
placebo group
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra
Active Comparator: Feno
Fenofibrate
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra
Active Comparator: ATV
Atorvastatin
Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632840

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

No publications provided by The University of Western Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald F Watts, University of Western Australia
ClinicalTrials.gov Identifier: NCT00632840     History of Changes
Other Study ID Numbers: UWA_DC012008
Study First Received: February 20, 2008
Last Updated: February 29, 2008
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Hypertriglyceridemia
Sphingolipidoses
Lipid Metabolism Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Atorvastatin
Fenofibrate
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents

ClinicalTrials.gov processed this record on October 02, 2014