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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00632840
Other study ID # UWA_DC012008
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2008
Last updated February 29, 2008
Start date June 2001
Est. completion date December 2007

Study information

Verified date February 2008
Source The University of Western Australia
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 2007
Est. primary completion date December 2002
Accepts healthy volunteers No
Gender Male
Age group 25 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Atorvastatin and fenofibrate
atorvastatin (40mg/day) fenofibrate (200mg/day)

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The University of Western Australia National Heart Foundation, Australia

Outcome

Type Measure Description Time frame Safety issue
Primary VLDL-apoC-III transport rate 5 weeks No
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