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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00392717




Registration number
NCT00392717
Ethics application status
Date submitted
25/10/2006
Date registered
26/10/2006
Date last updated
26/10/2006

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
EC-576
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
Obesity
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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
Cholesterol
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Triglyceride
Timepoint [2] 0 0
Secondary outcome [3] 0 0
LDL-cholesterol
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Adipocytokines
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Genetic polymorphisms
Timepoint [5] 0 0

Eligibility
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
Sex
Males
Can healthy volunteers participate?
Yes
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
Treatment
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
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00392717
Trial related presentations / publications
Public notes

Contacts
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