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Trial registered on ANZCTR


Registration number
ACTRN12609000382279
Ethics application status
Approved
Date submitted
12/05/2009
Date registered
29/05/2009
Date last updated
8/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Regulation of blood fat transport following a fatty test meal in lean men and men with the metabolic syndrome
Scientific title
Novel studies of postparandial lipoprotein metabolism in lean men and men with the metabolic syndrome
Secondary ID [1] 865 0
EC2009/014 Royal Perth Hospital Ethics Committee
Universal Trial Number (UTN)
Trial acronym
4P
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome and healthy lean control subjects 4760 0
Condition category
Condition code
Metabolic and Endocrine 237097 237097 0 0
Metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study. Imediately following a high fat test meal, intravenous D3-leucine stable isotope and two oral vitamin A capsules (50,000U each) will be used as kinetic tracers of lipoprotein metabolism. This wil be given only once and on one day only.
Intervention code [1] 4535 0
Not applicable
Comparator / control treatment
Age matched lean healty control subjects.
15 age-matched normolipidaemic men with a body mass index (BMI) <25kg/m2, waist circumference <102cm, triglycerides <1.0mmol/L, high density lipoprotein (HDL)-cholesterol =1.2 mmol/L, will also be recruited. All outcome measures will be compared with the metabolic syndrome groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5930 0
Area under the curve (AUC) for triglycerides will be used as an assessment tool for triglyceride metabolism. Plasma will be taken at all time points (baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours) and AUC for triglycerides will be determined and compared between groups. All analyses will be carried out using SPSS (SPSS, Inc., Chicago, USA). Group characteristics will be compared by t-tests and general linear modelling after logarithmmic transformation of skewed variables where appropriate. Associations will be examined by simple and multivariate linear regression method. Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [1] 5930 0
AUC time points are baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours
Secondary outcome [1] 242023 0
AUC for vitamin A will be used as an assessment tool for triglyceride concentrations. Plasma will be taken at all time points (baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours) and AUC for vitamin A will be determined and compared between groups. All analyses will be carried out using SPSS (SPSS, Inc., Chicago, USA). Group characteristics will be compared by t-tests and general linear modelling after logarithmmic transformation of skewed variables where appropriate. Associations will be examined by simple and multivariate linear regression method. Compartmental analysis will be used to develop and fit models to lipid and lipoprotein tracer data.
Timepoint [1] 242023 0
AUC time points are baseline, 5, 10, 20, 30, 40, 60mins, 1, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 8.0, 10.0, 24, 48, 72, 96 hours

Eligibility
Key inclusion criteria
All men will be aged 20-75yr and be non-smoking. 30 metabolic syndrome (MetS) men with a body mass index (BMI) <40kg/m will be recruited. The metabolic syndrome (MetS) will be defined by National Cholesterol Education Programme (NCEP) criteria as the presence of at least three of the following: waist circumference >102cm, triglycerides >1.7mmol/L, high densily lipoprotein (HDL)-cholesterol <1.05mmol/L, blood pressure >130/>85mm, and fasting glucose >6.1mmol/L. The 15 metabolic syndrome (MetS) men treated with Crestor will have a low density lipoprotein (LDL)-cholesterol <2.5mmol/L.
15 age-matched normolipidaemic men with a body mass index (BMI) <25kg/m2, waist circumference <102cm, triglycerides <1.0mmol/L, high density lipoprotein (HDL)-cholesterol =1.2 mmol/L, will also be recruited.
Minimum age
20 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects with plasma LDL-cholesterol >5mmo/L, diabetes mellitus, genetic hyperlipidaemia (e.g. familial hypercholesterolaemia (FH), consumption of >30g alcohol/day, apolipoprotein E2/E2 genotype, macroproteinuria, creatinaemia (>120?mol/L), hypothyroidism, and hepatic dysfunction (aspartate transaminase (AST) or alanine transaminase (ALT) >2x upper limit of normal (ULN), Creatine kinase >3x upper limit of normal (ULN) in Crestor treated subjects, major systemic illness and use of steroids or other agents that may influence lipid metabolism, cardiovascular event within past 6 months, subjects on hypocaloric diets, lactose intolerance or intolerance to cream or eggs, anaemia; any significant illness that in the opinion of reviewing physician would bear on the study (e.g. heart murmur or psychiatric conditions)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4946 0
Government body
Name [1] 4946 0
National Health and Medical Research Council (NHMRC) grant, Universtiy of Western Australia
Country [1] 4946 0
Australia
Primary sponsor type
Individual
Name
Professor Gerald Watts
Address
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country
Australia
Secondary sponsor category [1] 4465 0
None
Name [1] 4465 0
Address [1] 4465 0
Country [1] 4465 0
Other collaborator category [1] 668 0
Individual
Name [1] 668 0
Professor Hugh Barrett
Address [1] 668 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country [1] 668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7044 0
Royal Perth Hospital Ethics Commitee
Ethics committee address [1] 7044 0
Ethics committee country [1] 7044 0
Australia
Date submitted for ethics approval [1] 7044 0
03/02/2009
Approval date [1] 7044 0
03/03/2009
Ethics approval number [1] 7044 0
EC2009/014

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

Contacts
Principal investigator
Name 29594 0
Address 29594 0
Country 29594 0
Phone 29594 0
Fax 29594 0
Email 29594 0
Contact person for public queries
Name 12841 0
Sandra Hamilton
Address 12841 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country 12841 0
Australia
Phone 12841 0
+61 8 9224 0318
Fax 12841 0
+61 8 9224 0243
Email 12841 0
sandy.hamilton@uwa.edu.au
Contact person for scientific queries
Name 3769 0
Prof Hugh Barrett
Address 3769 0
School of Medicine and Pharmacology, Royal Perth Hospital, Rear 50 Murray Street, PO Box X2213, Perth, WA 6847
Country 3769 0
Australia
Phone 3769 0
+ 61 8 9224 0249
Fax 3769 0
+61 8 9224 0246
Email 3769 0
hugh.barrett@uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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