Pharmacological Regulation of Fat Transport in Metabolic Syndrome
Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
1 other identifier
interventional
11
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 obesity
Started Jun 2001
Longer than P75 for phase_4 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 20, 2008
CompletedFirst Posted
Study publicly available on registry
March 11, 2008
CompletedMarch 11, 2008
February 1, 2008
1.5 years
February 20, 2008
February 29, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
VLDL-apoC-III transport rate
5 weeks
Study Arms (3)
P
PLACEBO COMPARATORplacebo group
Feno
ACTIVE COMPARATORFenofibrate
ATV
ACTIVE COMPARATORAtorvastatin
Interventions
atorvastatin (40mg/day) fenofibrate (200mg/day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Chan DC, Watts GF, Ooi EM, Rye KA, Ji J, Johnson AG, Barrett PH. Regulatory effects of fenofibrate and atorvastatin on lipoprotein A-I and lipoprotein A-I:A-II kinetics in the metabolic syndrome. Diabetes Care. 2009 Nov;32(11):2111-3. doi: 10.2337/dc09-0519. Epub 2009 Aug 3.
PMID: 19651918DERIVEDChan DC, Barrett PH, Ooi EM, Ji J, Chan DT, Watts GF. Very low density lipoprotein metabolism and plasma adiponectin as predictors of high-density lipoprotein apolipoprotein A-I kinetics in obese and nonobese men. J Clin Endocrinol Metab. 2009 Mar;94(3):989-97. doi: 10.1210/jc.2008-1457. Epub 2008 Dec 30.
PMID: 19116237DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dick C Chan, PhD
The University of Western Australia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2008
First Posted
March 11, 2008
Study Start
June 1, 2001
Primary Completion
December 1, 2002
Study Completion
December 1, 2007
Last Updated
March 11, 2008
Record last verified: 2008-02