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COMPLETEDPhase 3NCT00392717

Regulation of Lipoprotein Metabolism in Obese Men

Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key characteristics of metabolic syn...

Lead sponsor: The University of Western Australia•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

The University of Western Australia

The study employed a factorial study design, stable isotopy and mathematical modelling to examine the independent and combined effects of decreasing cholesterol substrate availability with atorvastatin and decreasing triglyceride substrate availability with fish oils on lipoprotien kinetics (apoB, apoA, apoC-III and chylomicron remnants) in insulin-resistant men with visceral obesity.

Age

20 - 70 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Obesity was defined as a waist circumference \>100 cm, waist:hip ratio \>0.97 and BMI \>29 kg/m2.
•Subjects were selected for having insulin-resistance, defined as a homostasis model assessment (HOMA) score (21) \>5.1 (i.e. one SD above the mean for a reference population of 22 lean, normolipidemic healthy males of similar age).
•All subjects had plasma triglyceride \>1.2 mmol/L and cholesterol \>5.2 mmol/L at screening while consuming ad libitum, weight-maintaining diets

Exclusion Criteria

•diabetes mellitus, apolipoprotein E2/E2 genotype, macroproteinuria, creatinemia, hypothyrodism, or abnormal liver enzymes.
•Subjects did not consume fish oil supplements or drank more than 30g alcohol/day.
•None reported a history of CVD, or was taking medication or other agents known to affect lipid metabolism.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 26, 2006Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment48

Start dateFeb 1998

Last updatedOct 26, 2006

Condition

Obesity Dyslipidemia Insulin Resistance

Locations shown

Royal Perth Hospital

Perth, Western Australia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2006Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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