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

Tracking Information

First Received Date ^ICMJE

November 6, 2009

Last Updated Date

November 6, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cholesterol Metabolism and Lipid Transfer in Diabetes

Official Title ^ICMJE

Plasma Kinetics Study of Free Cholesterol and Cholesteryl Ester in Type 2 Diabetes Mellitus Patients

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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

whole blood samples

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

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

Study Group/Cohort (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01010035

Other Study ID Numbers ^ICMJE

LIPIDSDM

Has Data Monitoring Committee

Responsible Party

Antonio Carlos Lerario/ MD, PhD, university of são Paulo

Study Sponsor ^ICMJE

University of Sao Paulo General Hospital

Collaborators ^ICMJE

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators ^ICMJE

Principal Investigator:

Antonio C Lerario, MD, pHd

University of São Paulo

Information Provided By

University of Sao Paulo General Hospital

Verification Date

November 2009

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

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