Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01020578
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2009-11-24
Brief Title:
Low Density Lipoprotein LDL Cholesterol Metabolism in Impaired Glucose Tolerance
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Plasma Kinetics Study the of Free Cholesterol and Cholesterol Ester in Subjects With Impaired Glucose Tolerance
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Impaired glucose tolerance is associated with an increased risk of developing cardiovascular disease and atherosclerosis for reasons not yet totally understood Previous studies evaluated the kinetics of plasma LDL and a faster removal rate of free cholesterol in normolipidemic patients with diagnosed arterial coronary disease and deposits of this cholesterol on the blood vessel walls This disassociation of the cholesterol may suggest a new mechanism for not only the genesis but for the progression of arterial coronary disease The objective of this research was to study the plasma kinetics of free cholesterol and cholesterol ester in impaired glucose tolerance patient asymptomatic for coronary artery disease CAD to elucidate mechanisms involved in atherogenesis in these patients
Detailed Description:
Along with hyperglycemia the presence of obesity and dyslipidemia risk factors associated with the natural onset of diabetes mellitus type 2 could possibly explain the high susceptibility of the glucose intolerance to cardiovascular disease Dyslipidemia commonly linked to glucose intolerance is characterized by hypertriglyceridemia low HDL-C and in spite of the LDL-C being apparently normal or slightly elevated there is presence of small dense LDL Formulated in the laboratory an artificial lipid nanoemulsion marked with both 14C-cholesterol ester and 3H-cholesterol with lipid composition similar to LDL allows study the plasma kinetics of the two forms of cholesterol free and esterified The nanoemulsion mimics the natural LDL but is prepared without protein In contact with the bloodstream the nanoemulsion acquires apolipoproteins apo E preferentially allowing it to be recognized and removed from plasma by LDL receptor The application of this nanoemulsion was shown to be technically safe appropriate and simple to be used in humans in order to understand the role of dyslipidemia in the atherogenic process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None