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Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Sponsor
The University of Western Australia (Other)
Overall Status
Completed
CT.gov ID
NCT00632840
Collaborator
National Heart Foundation, Australia (Other)
11
Enrollment
3
Arms
78
Duration (Months)

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Jun 1, 2001
Actual Primary Completion Date :
Dec 1, 2002
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

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

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. VLDL-apoC-III transport rate [5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 70 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The University of Western Australia
    • National Heart Foundation, Australia

    Investigators

    • Principal Investigator: Dick C Chan, PhD, The University of Western Australia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00632840
    Other Study ID Numbers:
    • UWA_DC012008
    First Posted:
    Mar 11, 2008
    Last Update Posted:
    Mar 11, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Metabolic Syndrome
    Hypertriglyceridemia
    Lipid Metabolism Disorders
    Atorvastatin
    Fenofibrate

    Study Results

    No Results Posted as of Mar 11, 2008