Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Show all queries
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00395148
Registration number
NCT00395148
Ethics application status
Date submitted
31/10/2006
Date registered
2/11/2006
Date last updated
10/05/2011
Titles & IDs
Public title
Improving Metabolism With HDL Cholesterol
Query!
Scientific title
A Novel Mechanism Mediating Anti-atherosclerotic and Metabolic Actions of HDL Cholesterol
Query!
Secondary ID [1]
0
0
175/04
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Disease
0
0
Query!
Diabetes
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - rHDL
Treatment: Drugs: rHDL
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Metabolic parameters
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Query!
Eligibility
Key inclusion criteria
- Aged 18 - 65 years
- Free of overt coronary disease
- Body mass index <35 kg.m-2
- Fasting plasma glucose > 7 mmol/L-1
- No major illness
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Unable to give informed consent
- Smokers
- Abnormal LFT, U&E, FBE or creatinine
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
13
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Alfred Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3004 - Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Bayside Health
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Baker Heart Research Institute
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart
attack. This relates in part to the role good cholesterol plays in reducing build up of fat
in the arteries. However, good cholesterol has many other protective effects. We have
recently identified three enzymes (proteins) activated by HDL in cells lining the blood
vessels, which may be responsible for some of HDL's protective actions.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00395148
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bronwyn A Kingwell, PhD
Query!
Address
0
0
Baker Heart Research Institute
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00395148
Download to PDF
Show all queries