NCT01020578

Low Density Lipoprotein (LDL) Cholesterol Metabolism in Impaired Glucose Tolerance

Plasma Kinetics Study the of Free Cholesterol and Cholesterol Ester in Subjects With Impaired Glucose Tolerance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
OTHER	Plasma kinetic study	This study is done with the injection of an artificial lipid nanoemulsion doubly labeled with 14C-cholesteryl oleate and 3H-cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood samples collected in a pre established period of time in 24 hours.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2009-11-25
• Last updated: 2009-11-25

Locations

1 site across 1 country: Brazil