Pharmacological Regulation of Fat Transport in Metabolic Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00632840

Enrollment

Registered

2008-03-11

Start date

2001-06-30

Completion date

2007-12-31

Last updated

2008-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Hypertriglyceridemia, Lipid Disorders, Obesity

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.

Detailed 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.

Interventions

DRUGAtorvastatin and fenofibrate

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

25 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame
VLDL-apoC-III transport rate	5 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026