Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
26 participants
OBSERVATIONAL
2006-09-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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type 2 diabetes
patients with diagnosis of Type 2 diabetes mellitus
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.
Control
non type 2 diabetes mellitus
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
Yes
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo General Hospital
OTHER
Responsible Party
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university of são Paulo
Principal Investigators
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Antonio C Lerario, MD, pHd
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Endocrinology service and Lipid laboratory of Heart Institute of University of São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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LIPIDSDM
Identifier Type: -
Identifier Source: org_study_id
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