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Improving Metabolism With HDL Cholesterol

Primary Purpose

Heart Disease, Diabetes

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
rHDL
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Alfred Hospital

Outcomes

Primary Outcome Measures

Metabolic parameters

Secondary Outcome Measures

Full Information

First Posted
October 31, 2006
Last Updated
May 9, 2011
Sponsor
Bayside Health
Collaborators
Baker Heart Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00395148
Brief Title
Improving Metabolism With HDL Cholesterol
Official Title
A Novel Mechanism Mediating Anti-atherosclerotic and Metabolic Actions of HDL Cholesterol
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health
Collaborators
Baker Heart Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rHDL
Primary Outcome Measure Information:
Title
Metabolic parameters

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Unable to give informed consent Smokers Abnormal LFT, U&E, FBE or creatinine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bronwyn A Kingwell, PhD
Organizational Affiliation
Baker Heart Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21498847
Citation
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.
Results Reference
result
PubMed Identifier
21224289
Citation
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.
Results Reference
result
PubMed Identifier
19901191
Citation
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.
Results Reference
result
PubMed Identifier
19349317
Citation
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.
Results Reference
result
PubMed Identifier
19281927
Citation
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.
Results Reference
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Improving Metabolism With HDL Cholesterol

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