Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Obesity Clinical Trial

Official title:

Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632840
• Other study ID #: UWA_DC012008
• 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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertriglyceridemia
• Lipid Disorders
• Lipid Metabolism Disorders
• Metabolic Syndrome X
• Obesity

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