Lipid Metabolism, Inborn Errors Clinical Trial
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00092898 -
An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)
|
Phase 3 | |
Completed |
NCT00004481 -
Genetic Study of Sitosterolemia
|
N/A | |
Completed |
NCT00477594 -
Open Label Extension of ISIS 301012 (Mipomersen) to Treat Familial Hypercholesterolemia
|
Phase 2 | |
Not yet recruiting |
NCT02707211 -
Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases
|
Phase 0 | |
Active, not recruiting |
NCT05425745 -
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
|
Phase 3 | |
Completed |
NCT00607373 -
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
|
Phase 3 | |
Completed |
NCT00362180 -
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
|
Phase 2 | |
Terminated |
NCT00092833 -
Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
|
Phase 3 | |
Active, not recruiting |
NCT02635269 -
Fat and Sugar Metabolism During Exercise in Patients With Metabolic Myopathy
|
N/A | |
Terminated |
NCT00260299 -
Dietary Cholesterol and Defects in Cholesterol Synthesis in Mevalonate Kinase Deficiency
|
||
Completed |
NCT00092807 -
Sitosterolemia Extension Study (0653-003)(COMPLETED)
|
Phase 3 | |
Completed |
NCT00092820 -
Sitosterolemia Extension Study (0653-004)(COMPLETED)
|
Phase 3 | |
Completed |
NCT00694109 -
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia
|
Phase 3 |