Pharmacological Regulation of Fat Transport in Metabolic Syndrome

The University of Western Australia

Status and phase: Completed; Phase 4

Conditions: Hypertriglyceridemia; Obesity; Lipid Disorders; Cardiovascular Disease

Treatments: Drug: Atorvastatin and fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00632840

UWA_DC012008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 3 patient groups, including a placebo group

P

Placebo Comparator group

Description:

placebo group

Treatment:

Drug: Atorvastatin and fenofibrate

Feno

Active Comparator group

Description:

Fenofibrate

Treatment:

Drug: Atorvastatin and fenofibrate

ATV

Active Comparator group

Description:

Atorvastatin

Treatment:

Drug: Atorvastatin and fenofibrate