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Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Primary Purpose

Obesity, Lipid Disorders, Hypertriglyceridemia

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Atorvastatin and fenofibrate

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Feno

ATV

Arm Description

placebo group

Fenofibrate

Atorvastatin

Outcomes

Primary Outcome Measures

VLDL-apoC-III transport rate

Secondary Outcome Measures

Full Information

NCT ID

NCT00632840

First Posted

February 20, 2008

Last Updated

February 29, 2008

Sponsor

The University of Western Australia

Collaborators

National Heart Foundation, Australia

1. Study Identification

Unique Protocol Identification Number

NCT00632840

Brief Title

Pharmacological Regulation of Fat Transport in Metabolic Syndrome

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

June 2001 (undefined)

Primary Completion Date

December 2002 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Western Australia

Collaborators

National Heart Foundation, Australia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Lipid Disorders, Hypertriglyceridemia, Cardiovascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo group

Arm Title

Feno

Arm Type

Active Comparator

Arm Description

Fenofibrate

Arm Title

ATV

Arm Type

Active Comparator

Arm Description

Atorvastatin

Intervention Type

Drug

Intervention Name(s)

Atorvastatin and fenofibrate

Other Intervention Name(s)

Lipitor, Lofibra

Intervention Description

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

Primary Outcome Measure Information:

Title

VLDL-apoC-III transport rate

Time Frame

5 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dick C Chan, PhD

Organizational Affiliation

The University of Western Australia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19651918

Citation

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. doi: 10.2337/dc09-0519. Epub 2009 Aug 3.

Results Reference

derived

PubMed Identifier

19116237

Citation

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. doi: 10.1210/jc.2008-1457. Epub 2008 Dec 30.

Results Reference

derived

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Pharmacological Regulation of Fat Transport in Metabolic Syndrome

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