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CompletedNCT00395148Updated May 10, 2011

Improving Metabolism With HDL Cholesterol

An interventional study of rHDL in Heart Disease and Diabetes, sponsored by Bayside Health. Completed at 1 site in Australia. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-05-10.

Sponsored by Bayside Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
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Study 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.

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Conditions studied

  • Heart Disease
  • Diabetes

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 13 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Bayside Health is the lead sponsor of 110 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion criteria

Exclusion Criteria:

  • Unable to give informed consent
  • Smokers
  • Abnormal LFT, U\&E, FBE or creatinine
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
13 participants (actual)

Interventions

  • DrugrHDL
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What researchers measure

Primary outcomes

  1. Metabolic parameters

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Study locations

1 site
  • Alfred Hospital
    Melbourne, Victoria 3004, Australia
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References and documents

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. PubMed 21498847 ↗
  • 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. PubMed 21224289 ↗
  • 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. PubMed 19901191 ↗
  • 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. PubMed 19349317 ↗
  • 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. PubMed 19281927 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00395148
Lead sponsor
Bayside Health
Collaborators
Baker Heart Research Institute
First posted
Nov 2, 2006
Start date
Mar 2006
Primary completion
Mar 2008
Completion
Mar 2008
Last update
May 10, 2011

Study contacts

Bronwyn A Kingwell, PhD
principal investigator · Baker Heart Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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