Pharmacological Regulation of Fat Transport in Metabolic Syndrome - Full Text View

Sponsor:	The University of Western Australia
Collaborator:	National Heart Foundation, Australia
Information provided by:	The University of Western Australia
ClinicalTrials.gov Identifier:	NCT00632840

Purpose

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.

Condition	Intervention	Phase
Obesity Lipid Disorders Hypertriglyceridemia Cardiovascular Disease	Drug: Atorvastatin and fenofibrate	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Metabolic Syndrome Obesity Triglycerides

Drug Information available for: Fenofibrate Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by The University of Western Australia:

Primary Outcome Measures:

VLDL-apoC-III transport rate [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	June 2001
Study Completion Date:	December 2007
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: P placebo group	Drug: Atorvastatin and fenofibrate atorvastatin (40mg/day) fenofibrate (200mg/day) Other Names: Lipitor Lofibra
Active Comparator: Feno Fenofibrate	Drug: Atorvastatin and fenofibrate atorvastatin (40mg/day) fenofibrate (200mg/day) Other Names: Lipitor Lofibra
Active Comparator: ATV Atorvastatin	Drug: Atorvastatin and fenofibrate atorvastatin (40mg/day) fenofibrate (200mg/day) Other Names: Lipitor Lofibra

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632840

Sponsors and Collaborators

The University of Western Australia

National Heart Foundation, Australia

Investigators

Principal Investigator:

Dick C Chan, PhD

The University of Western Australia

More Information

No publications provided by The University of Western Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chan DC, Watts GF, Ooi EM, Rye KA, Ji J, Johnson AG, Barrett PH. Regulatory effects of fenofibrate and atorvastatin on lipoprotein A-I and lipoprotein A-I:A-II kinetics in the metabolic syndrome. Diabetes Care. 2009 Nov;32(11):2111-3. Epub 2009 Aug 3.

Chan DC, Barrett PH, Ooi EM, Ji J, Chan DT, Watts GF. Very low density lipoprotein metabolism and plasma adiponectin as predictors of high-density lipoprotein apolipoprotein A-I kinetics in obese and nonobese men. J Clin Endocrinol Metab. 2009 Mar;94(3):989-97. Epub 2008 Dec 30.

Responsible Party:	Gerald F Watts, University of Western Australia
ClinicalTrials.gov Identifier:	NCT00632840 History of Changes
Other Study ID Numbers:	UWA_DC012008
Study First Received:	February 20, 2008
Last Updated:	February 29, 2008
Health Authority:	Australia: Human Research Ethics Committee

Additional relevant MeSH terms:

Cardiovascular Diseases
Hypertriglyceridemia
Obesity
Lipid Metabolism Disorders
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance

Hyperinsulinism
Glucose Metabolism Disorders
Fenofibrate
Atorvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2012