NCT01020578

Brief Summary

Impaired glucose tolerance is associated with an increased risk of developing cardiovascular disease and atherosclerosis for reasons not yet totally understood. Previous studies evaluated the kinetics of plasma LDL and a faster removal rate of free cholesterol in normolipidemic patients with diagnosed arterial coronary disease and deposits of this cholesterol on the blood vessel walls. This disassociation of the cholesterol may suggest a new mechanism for not only the genesis but for the progression of arterial coronary disease. The objective of this research was to study the plasma kinetics of free cholesterol and cholesterol ester in impaired glucose tolerance patient, asymptomatic for coronary artery disease (CAD), to elucidate mechanisms involved in atherogenesis in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

November 24, 2009

Last Update Submit

November 24, 2009

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

  • Blood samples were used to determine the removal of the free and esterified cholesterol in impaired glucose tolerance patients.

    day of test

Study Arms (2)

Impaired glucose tolerance

Patients diagnosed with impaired glucose tolerance

Other: Plasma kinetic study

Control

Patients with normal blood glucose

Other: Plasma kinetic study

Interventions

Plasma kinetic studyOTHER

This study is done with the injection of an artificial lipid nanoemulsion doubly labeled with 14C-cholesteryl oleate and 3H-cholesterol, with a total radioactivity injection dose of 0.03mSV. Blood samples collected in a pre established period of time in 24 hours.

Also known as: Artificial lipid nanoemulsion
ControlImpaired glucose tolerance

Eligibility Criteria

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

Patients with impaired glucose tolerance and controls were recruited from the Hospital of Clinics, Some were patients and staff of the Heart Institute and patients treated in outpatient clinics, offices and clinics outside the Hospital of Clinics of University of São Paulo.

You may qualify if:

  • total cholesterol \< 6mmol/L
  • LDL-C \< 4mmol/L
  • triacylglycerides \< 2.2mmol/L
  • with normal blood pressure or hypertension until 130/85 mmHg

You may not qualify if:

  • presence of previous cardiovascular disease: macrovascular, peripheral arterial disease and cerebral stroke.
  • presence of chronic disease: chronic renal failure (creatinin \>30 ug/mg), hepatic failure, asthma, chronic obstructive pulmonary disease, inflammatory disease, oncology and thyropathy compensated.
  • use of drugs: statins, fibrates, glucocorticoids and metformin

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, Brazil

Location

Related Publications (3)

  • 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

  • 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

  • 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood samples

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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 24, 2009

First Posted

November 25, 2009

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

BR(1)