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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Other: Plasma kinetic study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Plasma Kinetics Study of Free Cholesterol and Cholesteryl Ester in Type 2 Diabetes Mellitus Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

whole blood samples


Enrollment: 26
Study Start Date: September 2006
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
type 2 diabetes
patients with diagnosis of 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
Control
non 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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010035

Locations
Brazil
Endocrinology service and Lipid laboratory of Heart Institute of University of São Paulo
São Paulo, Brazil, 05423000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Antonio C Lerario, MD, pHd University of São Paulo
  More Information

Publications:
Responsible Party: Antonio Carlos Lerario/ MD, PhD, university of são Paulo
ClinicalTrials.gov Identifier: NCT01010035     History of Changes
Other Study ID Numbers: LIPIDSDM
Study First Received: November 6, 2009
Last Updated: November 6, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
type 2 diabetes mellitus
dyslipidemia
kinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 27, 2014