Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000152527
Ethics application status
Approved
Date submitted
28/04/2006
Date registered
2/05/2006
Date last updated
11/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Lifestyle and pharmacological regulation of lipoprotein metabolism in the metabolic syndrome
Scientific title
Effect of weight loss and ezetimibe on high-density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL apoA-II transport in obese dyslipidaemic patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 1124 0
Type 2 diabetic mellitus 1125 0
Dyslipidaemia 1126 0
Condition category
Condition code
Diet and Nutrition 1202 1202 0 0
Obesity
Metabolic and Endocrine 1203 1203 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weight loss plus Ezetimibe (12 week diet restricting weight reduction program followed with 4 week weight stabilizing period; ezetimibe, 10mg/day, is administrated in form of oral tablet for 16 weeks)
Intervention code [1] 994 0
Treatment: Other
Comparator / control treatment
Weight loss (12 week diet restricting weight reduction program followed with 4 week weight stabilizing period)
Control group
Active

Outcomes
Primary outcome [1] 1631 0
High density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL-apoA-II production rates
Timepoint [1] 1631 0
Before and after 16 week intervention program
Primary outcome [2] 1632 0
High density lipoprotein (HDL)-apolipoprotein (apo) A-I and HDL-apoA-II catabolic rates
Timepoint [2] 1632 0
Before and after 16 week intervention program
Secondary outcome [1] 2925 0
Apo B production and catabolic rates
Timepoint [1] 2925 0
Before and after 16 week intervention program.
Secondary outcome [2] 2926 0
Cholesterol absorption and synthesis
Timepoint [2] 2926 0
Before and after 16 week intervention program.

Eligibility
Key inclusion criteria
BMI <40kg/m2 will be recruited. PM will be defined by: no menstrual cycle for 1 year and FSH >30U/L, or if the subject has had a hysterectomy or surgical sterilization. The MetS will be defined by the new International Diabetes Federation (IDF) criteria: central obesity (waist circumference >80cm for women and >94cm for men) plus triglycerides =1.7mmol/L, non-HDL-cholesterol >3.4mmol/L and insulin resistance (HOMA >2.2).Exclusion: Subjects with genetic hyperlipidemia, (eg FH), LDL-cholesterol >6.5mmol/L, proteinuria, hypothyroidism, alcoholism (>30g/day), creatinaemia (>130µmol/L), hepatic dysfunction (AST or ALT >3x ULN) and major systemic illness; pre-menopause women; use of steroids or other agents that may influence lipid metabolism, cardiovascular event within past 6 months, use of hypocaloric diets, anaemia; a history of intolerance to ezetimibe.
Minimum age
40 Years
Maximum age
75 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 statistican not involved in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1315 0
Government body
Name [1] 1315 0
National Health and Medical Research Council
Country [1] 1315 0
Australia
Funding source category [2] 1316 0
Charities/Societies/Foundations
Name [2] 1316 0
National Heart Foundation of Australia
Country [2] 1316 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 1162 0
None
Name [1] 1162 0
Nil
Address [1] 1162 0
Country [1] 1162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2644 0
Royal Perth Hospital
Ethics committee address [1] 2644 0
Ethics committee country [1] 2644 0
Australia
Date submitted for ethics approval [1] 2644 0
Approval date [1] 2644 0
21/02/2006
Ethics approval number [1] 2644 0
EC2006/070

Summary
Brief summary
The study hypothesis is that inhibition of cholesterol absorption complements the effects of weight loss on lipid and lipoprotein transport in obese subjects. Specifically , the study aims to elucidate the mechanisms of action of a new therapeutic regimen (weight loss plus ezetimibe) for regulating lipid and lipoprotein transport in these subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35509 0
Address 35509 0
Country 35509 0
Phone 35509 0
Fax 35509 0
Email 35509 0
Contact person for public queries
Name 10183 0
Prof Gerald F Watts
Address 10183 0
School of Medicine and Pharmacology
University of Western Australia
Level 4, MRF Building
Royal Perth Hospital
50 Murray Street, Perth WA6000
Country 10183 0
Australia
Phone 10183 0
61-8-92240251
Fax 10183 0
Email 10183 0
gfwatts@cyllene.uwa.edu.au
Contact person for scientific queries
Name 1111 0
Dr Dick C Chan
Address 1111 0
School of Medicine and Pharmacology
University of Western Australia
Level 4 MRF Building
Royal Perth Hospital
50 Murray Street Perth WA6000
Country 1111 0
Australia
Phone 1111 0
61-8-92240268
Fax 1111 0
Email 1111 0
dick.chan@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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.