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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Other: Plasma kinetic study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: total cholesterol < 6mmol/L LDL-C < 4mmol/L triacylglycerides < 2.2mmol/L with normal blood pressure or hypertension until 130/85 mmHg Exclusion Criteria: presence of previous cardiovascular disease: macrovascular, peripheral arterial disease and cerebral stroke. presence of chronic disease: chronic renal failure (creatinin >30 ug/mg), hepatic failure, asthma, chronic obstructive pulmonary disease, inflammatory disease, oncology and thyropathy compensated. use of drugs: statins, fibrates, glucocorticoids and metformin

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Impaired glucose tolerance<br>Patients diagnosed with impaired glucose tolerance | Other: Plasma kinetic study<br>* 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.<br>* Other names: Artificial lipid nanoemulsion;|
| Control<br>Patients with normal blood glucose | Other: Plasma kinetic study<br>* 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.<br>* Other names: Artificial lipid nanoemulsion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples were used to determine the removal of the free and esterified cholesterol in impaired glucose tolerance patients. |  | day of test |