Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Lipid Disorders Hypertriglyceridemia Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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P

placebo group

Group Type PLACEBO_COMPARATOR

Atorvastatin and fenofibrate

Intervention Type DRUG

atorvastatin (40mg/day) fenofibrate (200mg/day)

Feno

Fenofibrate

Group Type ACTIVE_COMPARATOR

Atorvastatin and fenofibrate

Intervention Type DRUG

atorvastatin (40mg/day) fenofibrate (200mg/day)

ATV

Atorvastatin

Group Type ACTIVE_COMPARATOR

Atorvastatin and fenofibrate

Intervention Type DRUG

atorvastatin (40mg/day) fenofibrate (200mg/day)

Interventions

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Atorvastatin and fenofibrate

atorvastatin (40mg/day) fenofibrate (200mg/day)

Intervention Type DRUG

Other Intervention Names

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Lipitor Lofibra

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No