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Trial record 9 of 23 for:    "Hyperinsulinism" | "Fenofibrate"

Pharmacological Regulation of Fat Transport in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT00632840
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : March 11, 2008
Sponsor:
Collaborator:
National Heart Foundation, Australia
Information provided by:
The University of Western Australia

Tracking Information
First Submitted Date  ICMJE February 20, 2008
First Posted Date  ICMJE March 11, 2008
Last Update Posted Date March 11, 2008
Study Start Date  ICMJE June 2001
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
VLDL-apoC-III transport rate [ Time Frame: 5 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacological Regulation of Fat Transport in Metabolic Syndrome
Official Title  ICMJE Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Lipid Disorders
  • Hypertriglyceridemia
  • Cardiovascular Disease
Intervention  ICMJE Drug: Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)
Other Names:
  • Lipitor
  • Lofibra
Study Arms  ICMJE
  • Placebo Comparator: P
    placebo group
    Intervention: Drug: Atorvastatin and fenofibrate
  • Active Comparator: Feno
    Fenofibrate
    Intervention: Drug: Atorvastatin and fenofibrate
  • Active Comparator: ATV
    Atorvastatin
    Intervention: Drug: Atorvastatin and fenofibrate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 29, 2008)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632840
Other Study ID Numbers  ICMJE UWA_DC012008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerald F Watts, University of Western Australia
Study Sponsor  ICMJE The University of Western Australia
Collaborators  ICMJE National Heart Foundation, Australia
Investigators  ICMJE
Principal Investigator: Dick C Chan, PhD The University of Western Australia
PRS Account The University of Western Australia
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP