NCT00395148

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 10, 2011

Status Verified

October 1, 2006

Enrollment Period

2 years

First QC Date

October 31, 2006

Last Update Submit

May 9, 2011

Conditions

Heart DiseaseDiabetes

Outcome Measures

Primary Outcomes (1)

  • Metabolic parameters

Interventions

rHDLDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Publications (5)

  • 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.

    PMID: 21498847RESULT

  • 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.

    PMID: 21224289RESULT

  • 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.

    PMID: 19901191RESULT

  • 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.

    PMID: 19349317RESULT

  • 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.

    PMID: 19281927RESULT

MeSH Terms

Conditions

Heart DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bronwyn A Kingwell, PhD

    Baker Heart Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 2, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 10, 2011

Record last verified: 2006-10

Locations

AU(1)