Clinical Trial: Mendelian Reverse Cholesterol Transport Study
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Validation Study Evaluating the Use of 3H-Cholesterol Bound to Albumin as a Method to Assess Reverse Cholesterol Transport in Subjects With Monogenic Diseases Affecting HDL Metabolism
Brief Summary: The purpose of this study is to investigate the use of radiolabeled particulate cholesterol administered intravenously in association with albumin, as a method to study reverse cholesterol transport (RCT) in people carrying mutations in genes known to affect high density lipoprotein (HDL) metabolism by analyzing changes in the tracer activity in total plasma, lipoproteins fractions and feces.
Detailed Summary:
The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the ability of HDL to transport cholesterol from the periphery to the liver to be eliminated. This process is called reverse cholesterol transport (RCT) and is one of the main mechanisms by which HDL protect against atherosclerotic cardiovascular disease. Mutations in some of the genes affecting HDL metabolism, may results in changes in RCT. The validation of a method assessing RCT is important for the development of new drugs which affect RCT and may result in useful treatments for atherosclerosis.
Subjects carrying mutations in genes known to affect HDL metabolism and healthy controls will be enrolled in the study. Changes in the tracer activity in total plasma, lipoproteins fractions and feces will be analyzed following the intravenous administration of radiolabeled particulate cholesterol.
Sponsor: University of Pennsylvania
Current Primary Outcome: determination of 3H cholesterol in plasma and lipoproteins [ Time Frame: up to 192 hr ]
Original Primary Outcome: Same as current
Current Secondary Outcome: determination of 3H cholesterol and its metabolites in red blood cells over time [ Time Frame: up to 192 hr ]
Original Secondary Outcome:
- determination of 3H cholesterol and its metabolites in red blood cells over time [ Time Frame: up to 192 hr ]
- determination of 3H cholesterol and its metabolites in feces over time [ Time Frame: up to 192 hr ]
Information By: University of Pennsylvania
Dates:
Date Received: January 30, 2013
Date Started: October 2012
Date Completion: January 2017
Last Updated: July 29, 2016
Last Verified: July 2016
