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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01020578
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Impaired Glucose Tolerance
Other: Plasma kinetic study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Plasma Kinetics Study the of Free Cholesterol and Cholesterol Ester in Subjects With Impaired Glucose Tolerance

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Blood samples were used to determine the removal of the free and esterified cholesterol in impaired glucose tolerance patients. [ Time Frame: day of test ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood samples


Enrollment: 29
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Impaired glucose tolerance
Patients diagnosed with impaired glucose tolerance
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.
Other Name: Artificial lipid nanoemulsion
Control
Patients with normal blood glucose
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.
Other Name: Artificial lipid nanoemulsion

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with impaired glucose tolerance and controls were recruited from the Hospital of Clinics, Some were patients and staff of the Heart Institute and patients treated in outpatient clinics, offices and clinics outside the Hospital of Clinics of University of São Paulo.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020578

Locations
Brazil
Endocrinology Service and Lipid Laboratory of Heart Institute of University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Antonio C Lerario, MD, pHD University of São Paulo
  More Information