Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cholesterol Metabolism and Lipid Transfer in Diabetes

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:
NCT01010035
First received: November 6, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted

November 6, 2009
November 6, 2009
September 2006
January 2009   (final data collection date for primary outcome measure)
to identify the removal of the free and esterified cholesterol in type 2 diabetes patients [ Time Frame: day of test ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Cholesterol Metabolism and Lipid Transfer in Diabetes
Plasma Kinetics Study of Free Cholesterol and Cholesteryl Ester in Type 2 Diabetes Mellitus Patients

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

whole blood samples

Non-Probability Sample

outpatient of the endocrinology clinics of Hospital das clinicas of University of São Paulo Medical school

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 Name: LDL-like nanoemulsion
  • type 2 diabetes
    patients with diagnosis of Type 2 diabetes mellitus
    Intervention: Other: Plasma kinetic study
  • Control
    non type 2 diabetes mellitus
    Intervention: Other: Plasma kinetic study

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01010035
LIPIDSDM
No
Antonio Carlos Lerario/ MD, PhD, university of são Paulo
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Antonio C Lerario, MD, pHd University of São Paulo
University of Sao Paulo General Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP