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Regulation of Lipoprotein Metabolism in Obese Men

NCT ID: NCT00392717

Last Updated: 2006-10-26

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

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2002-03-31

Brief Summary

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Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that the risk of CVD is increased in subjects with the MetS. The precise reason for this remains unclear, but appears to be closely related with dyslipidaemia. Effective management of dyslipidaemia is important to reduce the risk of CVD in these subjects.

Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis by fish oils improve lipoprotein metabolism in visceral obese men.

Detailed Description

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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.

Conditions

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Obesity Dyslipidemia Insulin Resistance

Keywords

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lipoprotein metabolism cardiovascular disease obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atorvastatin

Intervention Type DRUG

Fish oils

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Western Australia

OTHER

Sponsor Role lead

Principal Investigators

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Dick C Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Gerald F Watts, MBBS PhD

Role: STUDY_CHAIR

The University of Western Australia

P Hugh H Barrett, PhD

Role: STUDY_DIRECTOR

The University of Western Australia

Locations

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Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 19116237 (View on PubMed)

Other Identifiers

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EC-576

Identifier Type: -

Identifier Source: org_study_id