NCT01010035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

2.3 years

First QC Date

November 6, 2009

Last Update Submit

November 6, 2009

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitusdyslipidemiakinetics

Outcome Measures

Primary Outcomes (1)

  • to identify the removal of the free and esterified cholesterol in type 2 diabetes patients

    day of test

Study Arms (2)

type 2 diabetes

patients with diagnosis of Type 2 diabetes mellitus

Other: Plasma kinetic study

Control

non type 2 diabetes mellitus

Other: Plasma kinetic study

Interventions

Plasma kinetic studyOTHER

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.

Also known as: LDL-like nanoemulsion
Controltype 2 diabetes

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology service and Lipid laboratory of Heart Institute of University of São Paulo

São Paulo, São Paulo, 05423000, Brazil

Location

Related Publications (3)

  • Santos RD, Hueb W, Oliveira AA, Ramires JA, Maranhao RC. Plasma kinetics of a cholesterol-rich emulsion in subjects with or without coronary artery disease. J Lipid Res. 2003 Mar;44(3):464-9. doi: 10.1194/jlr.M200331-JLR200. Epub 2002 Dec 1.

    PMID: 12562871BACKGROUND

  • Santos RD, Chacra AP, Morikawa A, Vinagre CC, Maranhao RC. Plasma kinetics of free and esterified cholesterol in familial hypercholesterolemia: effects of simvastatin. Lipids. 2005 Jul;40(7):737-43. doi: 10.1007/s11745-005-1437-6.

    PMID: 16196425BACKGROUND

  • Couto RD, Dallan LA, Lisboa LA, Mesquita CH, Vinagre CG, Maranhao RC. Deposition of free cholesterol in the blood vessels of patients with coronary artery disease: a possible novel mechanism for atherogenesis. Lipids. 2007 May;42(5):411-8. doi: 10.1007/s11745-007-3041-9. Epub 2007 Apr 19.

    PMID: 17443358BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Dyslipidemias

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Study Officials

  • Antonio C Lerario, MD, pHd

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

September 1, 2006

Primary Completion

January 1, 2009

Study Completion

May 1, 2009

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

BR(1)