Improving Metabolism With HDL Cholesterol

Diabetes Clinical Trial

Official title:

A Novel Mechanism Mediating Anti-atherosclerotic and Metabolic Actions of HDL Cholesterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395148
• Other study ID #: 175/04
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: May 9, 2011
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2006
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Heart Disease

Intervention

Drug:
• rHDL

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Bayside Health	Baker Heart Research Institute

Country where clinical trial is conducted

Australia, 

References & Publications (5)

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 eff — View 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 mellit — View 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 me — View 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 — View 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 choleste — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic parameters