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Cholesterol Metabolism and Lipid Transfer in Diabetes

U

University of Sao Paulo General Hospital

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Other: Plasma kinetic study

Study type

Observational

Funder types

Other

Identifiers

NCT01010035
LIPIDSDM

Details and patient eligibility

About

The diabetic dyslipidemia is one of the most important risk factor in the development of coronary artery disease. The low density lipoprotein (LDL)-like nanoemulsions is being used to study the clearance of cholesteryl ester and free cholesterol from intravascular in patients with advanced coronary artery disease and it was shown a higher removal of free cholesterol and higher deposit in vases of this patients. The aim of this study is to analyze the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes patients without a previous history of cardiovascular disease.

Full description

Hypercholesterolemia is not typical of type 2 diabetes mellitus dyslipidemia, but alterations in LDL may occur related to atherogenesis.Cholesterol exist in two main forms in organism: free cholesterol and the esterified cholesterol. An artificial model to study this two forms of cholesterol is the use of LDL-like nanoemulsion doubly labeled with 14C-cholesteryl esters and 3H- cholesterol. This nanoemulsion is made without protein and when in the intravascular compartment it is able to acquires apolipoproteins from others lipoproteins, such apos A's, C's and E. This model allowed us to use the nanoemulsion particle as a probe to study the lipoproteins receptor binding and the cholesterol esterification process.

Enrollment

26 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • without a previous cardiovascular disease
  • if arterial hypertension, or in use of antihypertensive drugs- it must be well controled with a systolic Blood pressure level <130mmHg and diastolic <85mmHg.
  • total cholesterol < 6 mmol/L
  • LDL- cholesterol <4 mmol/L

Exclusion criteria

  • use of drugs- statins, fibrates, glucocorticoids, thiazolidinediones
  • nephropathy- the presence of microalbuminuria(ratio of microalbuminuria/creatinin >30 ug/mg) or serum creatinin above 98umol/L in woman and above 115 umol/L in man
  • retinopathy
  • neuropathy presence of chronic disease: heart failure, chronic obstructive pulmonary disease, inflammatory disease and cancer

Trial design

26 participants in 2 patient groups

type 2 diabetes
Description:
patients with diagnosis of Type 2 diabetes mellitus
Treatment:
Other: Plasma kinetic study
Control
Description:
non type 2 diabetes mellitus
Treatment:
Other: Plasma kinetic study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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