Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000107628
Ethics application status
Approved
Date submitted
4/08/2005
Date registered
9/08/2005
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Date results information initially provided
12/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fatty acid metabolism and heart disease
Scientific title
A randomised trial to evaluate the effects of weight loss in the treatment of the metabolic syndrome on Cytochrome P-450 metabolites of Arachidonic acid
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 191 0
Condition category
Condition code
Metabolic and Endocrine 214 214 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive dietary counselling to reduce their energy intake by 2000-6500 kJ /day aiming to achieve a 5-8kg wight loss during the first 12 weeks. This will be followed by 12 weeks of stabilisation.
Intervention code [1] 119 0
Lifestyle
Comparator / control treatment
The control group will maintain their usual energy intake over the 16 week period.
Control group
Dose comparison

Outcomes
Primary outcome [1] 254 0
Changes cytochrome P450 metabolites of arachidonic acid in urine, plasma lipoproteins, and platelet membranes after intervention
Timepoint [1] 254 0
16 weeks
Primary outcome [2] 255 0
CYP-450 omega hydroxylase activity after intervention
Timepoint [2] 255 0
16 weeks
Primary outcome [3] 256 0
Weight after intervention
Timepoint [3] 256 0
16 weeks
Primary outcome [4] 257 0
Ambulatory BP and endothelial function after intervention
Timepoint [4] 257 0
16weeks
Primary outcome [5] 258 0
Glucose after intervention
Timepoint [5] 258 0
16 weeks
Primary outcome [6] 259 0
Lipids after intervention
Timepoint [6] 259 0
16 weeks
Secondary outcome [1] 581 0
Changes in serum insulin.
Timepoint [1] 581 0
16 weeks
Secondary outcome [2] 582 0
Changes in testosterone.
Timepoint [2] 582 0
16 weeks
Secondary outcome [3] 583 0
Changes in sex hormone binding globulin.
Timepoint [3] 583 0
16 weeks
Secondary outcome [4] 369403 0
Plasma Resolvins
Timepoint [4] 369403 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
Men aged 20-70 years and women (post-menopausal not taking hormone replacement therapy) who are non-smokers and not taking medication will be recruited if they have a waist circumference > 102cm males, > 88cm females and blood pressure >120/85 mmHg In addition they may also have the following National Cholesterol Education Program (NECP) criteria :- triglycerides > 1.7 mol/l; HDL-C <1.04 males, <1.3 females; fasting glucose > 6.1.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
central allocation by a statistician not involved in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation using computer generated random numbers by Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study does not use weight loss as a specific treament. Weight loss is the intervention used to alter our main outcome measures.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/01/2005
Actual
20/02/2005
Date of last participant enrolment
Anticipated
Actual
6/06/2006
Date of last data collection
Anticipated
Actual
12/12/2006
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 275 0
Charities/Societies/Foundations
Name [1] 275 0
National Heart foundation
Country [1] 275 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Puddey
Address
Faculty of Medicine and Dentistry University of Western Australia
Stirling Highway
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 207 0
Individual
Name [1] 207 0
Assoc Prof Kevin Croft
Address [1] 207 0
School of Medicine and Pharmacology University of Western Australia GPO Box X2213 Perth WA 6847
Country [1] 207 0
Australia
Secondary sponsor category [2] 208 0
Individual
Name [2] 208 0
Dr Anne Barden
Address [2] 208 0
School of Medicine and Pharmacology University of Western Australia GPO Box X2213 Perth WA 6847
Country [2] 208 0
Australia
Secondary sponsor category [3] 209 0
Individual
Name [3] 209 0
Professor Lawrie Beilin
Address [3] 209 0
School of Medicine and Pharmacology University of Western Australia GPO Box X2213 Perth WA 6847
Country [3] 209 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1123 0
University of Western Australia
Ethics committee address [1] 1123 0
Stirling Hwy, Nedlands 6009
Ethics committee country [1] 1123 0
Australia
Date submitted for ethics approval [1] 1123 0
Approval date [1] 1123 0
13/12/2004
Ethics approval number [1] 1123 0
RA/4/1/1131

Summary
Brief summary
Overweight people are at risk of developing heart disease due to their predisposition of also having high blood pressure, high blood fats and high blood sugar levels. This project examines the role of certain fatty acid metabolites called cytochrome P450 metabolites of arachidonic acid (CYP-450AA) in conditions associated with being overweight. These fatty acid metabolites act on blood vessels causing them to constrict or dilate. In doing this they affect blood pressure regulation. Being overweight or obese makes people vulnerable to developing diabetes and cardiovascular disease. This study will examine CYP-450AA in overweight men and women before and after weight reduction compared with overweight volunteers who maintain their weight over the same time period. This will enable us to see if the levels of fatty acid metabolites that constrict blood vessels are altered and related to a fall in blood pressure after weight reduction. This project will help scientists decide how important these metabolites are for blood pressure regulation in overweight people.
Trial website
Trial related presentations / publications
17. Tsai IJ, Beilin LJ Puddey IB Croft, KD Barden A. Impaired ex vivo leukotriene B-4 production characterizes the metabolic syndrome and is improved after weight reduction. J Clin Endocrinol Metab, 2007; 92 : 4747-4752.
18.
Public notes

Contacts
Principal investigator
Name 35621 0
Prof Ian Puddey
Address 35621 0
Medical School, University of Western Australia
Royal Perth Hospital Unit
MRF Building
Rear of 50 Murray St,
Perth. Western. Australia 6000
Country 35621 0
Australia
Phone 35621 0
+61 8 9224 0245
Fax 35621 0
Email 35621 0
ian.puddey@uwa.edu.au
Contact person for public queries
Name 9308 0
Professor Ian Puddey
Address 9308 0
Faculty of Medicine and Dentistry
University of Western Australia
Stirling Highway
Nedlands WA 6009
Country 9308 0
Australia
Phone 9308 0
+61 8 93463876
Fax 9308 0
+61 8 93462369
Email 9308 0
ian.puddey@uwa.edu.au
Contact person for scientific queries
Name 236 0
Dr Anne Barden
Address 236 0
School of Medicine and Pharmacology
University of Western Australia
GPO Box X2213
Perth WA 6847
Country 236 0
Australia
Phone 236 0
+61 8 92240272
Fax 236 0
+61 8 92240246
Email 236 0
anne.barden@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
information was confidential


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.