Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Novel Mechanism Mediating Anti-atherosclerotic and Metabolic Actions of HDL Cholesterol
Secondary ID [1] 0 0
175/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Disease 0 0
Diabetes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metabolic parameters
Timepoint [1] 0 0

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to give informed consent
* Smokers
* Abnormal LFT, U&E, FBE or creatinine

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00395148
Trial related presentations / publications
Hoang A, Drew BG, Low H, Remaley AT, Nestel P, Kingwell BA, Sviridov D. Mechanism of cholesterol efflux in humans after infusion of reconstituted high-density lipoprotein. Eur Heart J. 2012 Mar;33(5):657-65. doi: 10.1093/eurheartj/ehr103. Epub 2011 Apr 15.
Drew BG, Carey AL, Natoli AK, Formosa MF, Vizi D, Reddy-Luthmoodoo M, Weir JM, Barlow CK, van Hall G, Meikle PJ, Duffy SJ, Kingwell BA. Reconstituted high-density lipoprotein infusion modulates fatty acid metabolism in patients with type 2 diabetes mellitus. J Lipid Res. 2011 Mar;52(3):572-81. doi: 10.1194/jlr.P012518. Epub 2011 Jan 11.
Calkin AC, Drew BG, Ono A, Duffy SJ, Gordon MV, Schoenwaelder SM, Sviridov D, Cooper ME, Kingwell BA, Jackson SP. Reconstituted high-density lipoprotein attenuates platelet function in individuals with type 2 diabetes mellitus by promoting cholesterol efflux. Circulation. 2009 Nov 24;120(21):2095-104. doi: 10.1161/CIRCULATIONAHA.109.870709. Epub 2009 Nov 9.
Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.
Patel S, Drew BG, Nakhla S, Duffy SJ, Murphy AJ, Barter PJ, Rye KA, Chin-Dusting J, Hoang A, Sviridov D, Celermajer DS, Kingwell BA. Reconstituted high-density lipoprotein increases plasma high-density lipoprotein anti-inflammatory properties and cholesterol efflux capacity in patients with type 2 diabetes. J Am Coll Cardiol. 2009 Mar 17;53(11):962-71. doi: 10.1016/j.jacc.2008.12.008.
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn A Kingwell, PhD
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00395148