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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Regulation of Lipoprotein Metabolism in Obese Men
Scientific title
Effect of Atorvastatin and Fish Oils on Lipoprotein Metabolism in Visceral Obesity
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Dyslipidemia 0 0
Insulin Resistance 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Fish oils

Treatment: Drugs: Atorvastatin

Treatment: Drugs: Fish oils

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Fractional catabolic rate of apoB, apoA, apoC-III and chylomicron remnants (before and after 6 week treatments)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Production rate of apoB, apoA, apoC-III and chylomicron remnants (before and after 6 week treatments)
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Genetic polymorphisms
Timepoint [5] 0 0

Key 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
Minimum age
20 Years
Maximum age
70 Years
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
The University of Western Australia

Ethics approval
Ethics application status

Brief summary
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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Dick C Chan, PhD
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications