Cholesterol Metabolism and Lipid Transfer in Diabetes

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01010035
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
26
1
32
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Plasma kinetic study

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
26 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Plasma Kinetics Study of Free Cholesterol and Cholesteryl Ester in Type 2 Diabetes Mellitus Patients
Study Start Date :
Sep 1, 2006
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
type 2 diabetes

patients with diagnosis of Type 2 diabetes mellitus

Other: Plasma kinetic study
this study is done with the injection of LDL-like nanoemulsion doubly labeled with 14C- cholesteryl oleate and 3H- cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood sample collected in a pre established period of time in 24 hours.
Other Names:
  • LDL-like nanoemulsion
  • Control

    non type 2 diabetes mellitus

    Other: Plasma kinetic study
    this study is done with the injection of LDL-like nanoemulsion doubly labeled with 14C- cholesteryl oleate and 3H- cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood sample collected in a pre established period of time in 24 hours.
    Other Names:
  • LDL-like nanoemulsion
  • Outcome Measures

    Primary Outcome Measures

    1. to identify the removal of the free and esterified cholesterol in type 2 diabetes patients [day of test]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Endocrinology service and Lipid laboratory of Heart Institute of University of São Paulo São Paulo Brazil 05423000

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01010035
    Other Study ID Numbers:
    • LIPIDSDM
    First Posted:
    Nov 9, 2009
    Last Update Posted:
    Nov 9, 2009
    Last Verified:
    Nov 1, 2009
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2009