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

Completed

• Conditions: Impaired Glucose Tolerance
• Interventions: Other: Plasma kinetic study

• Registration Number: NCT01020578
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Study Start: 2008-06
• Primary Completion: 2009-07
• Study Completion: 2009-10
• Status Verified: 2009-11
• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Last Update Submitted: 2009-11-24
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Impaired glucose tolerance	Plasma kinetic study	Patients diagnosed with impaired glucose tolerance
Control	Plasma kinetic study	Patients with normal blood glucose

Primary Outcome Measures

Name	Time	Method
Blood samples were used to determine the removal of the free and esterified cholesterol in impaired glucose tolerance patients.	day of test

Trial Locations

Locations (1)

Endocrinology Service and Lipid Laboratory of Heart Institute of University of São Paulo; 🇧🇷 São Paulo, Brazil