Cholesterol Metabolism and Lipid Transfer in Diabetes

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Plasma kinetic study

• Registration Number: NCT01010035
• Lead Sponsor: University of Sao Paulo General Hospital

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 Timeline

• Study Start: 2006-09
• Primary Completion: 2009-01
• Study Completion: 2009-05
• Status Verified: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Last Update Submitted: 2009-11-06
• Study First Posted: 2009-11-09
• Last Update Posted: 2009-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
type 2 diabetes	Plasma kinetic study	patients with diagnosis of Type 2 diabetes mellitus
Control	Plasma kinetic study	non type 2 diabetes mellitus

Primary Outcome Measures

Name	Time	Method
to identify the removal of the free and esterified cholesterol in type 2 diabetes patients	day of test

Trial Locations

Locations (1)

Endocrinology service and Lipid laboratory of Heart Institute of University of São Paulo; 🇧🇷 São Paulo, Brazil