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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00438061
Registration number
NCT00438061
Ethics application status
Date submitted
20/02/2007
Date registered
21/02/2007
Date last updated
26/02/2007
Titles & IDs
Public title
Effect of Abdominal Obesity on Lipoprotein Metabolism
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Scientific title
Effect of Weight Loss on Lipoprotein Metabolism in Abdominal Obesity
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Secondary ID [1]
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EC-256
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Dyslipidemia
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Insulin Resistance
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary: Fractional catabolic and production rates of LDL-apoB and HDL-apoA-I (before and after 16 week treatments)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Secondary: Cholesterol; Triglyceride; LDL-cholesterol; Adipocytokines; Genetic polymorphism
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
* Obesity was defined as a body mass index (BMI) >28kg/m2 and visceral visceral obesity (waist to hip ratio> 1.0 or waist circumference >100 cm)
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Diabetes mellitus,
* Proteinuria,
* Hypothyroidism,
* Abnormal liver enzymes,
* Major systemic illness,
* A history of alcohol abuse,
* A family history of hyperlipidemia or premature coronary artery disease or were taking medication known to affect lipid metabolism.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/1995
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Abdominal obesity is strongly associated with dyslipidemia, which may account for the associated increased risk of atherosclerosis and coronary disease. Weight reduction is suggested to be a preferred and effective first-line strategy to correct lipid abnormalities, particularly in overweight/obese subjects. This improvement may be related to the effect of reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully demonstrated. Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as well as decreasing HDL apoA-I, respectively.
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Trial website
https://clinicaltrials.gov/study/NCT00438061
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dick C Chan, PhD
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00438061
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