Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease
NCT ID: NCT03937284
Last Updated: 2019-05-03
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
45 participants
OBSERVATIONAL
2016-05-03
2017-10-20
Brief Summary
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The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD.
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Detailed Description
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Subjects and method Twenty patients with PD and twenty healthy controls were recruited for the study. Fasting blood samples were taken for routine laboratory analysis and for the separation of EDTA plasma. Plasma samples stored at -80°C until were used for lipoprotein isolation and analysis and for the measurement of lipid transfer protein and LPS levels.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Parkinson's patients
Patients with Parkinson disease evaluated in agreement with UK Brain Bank criteria
Patients not treated
Control group
Subject matched for sex, age and BMI
Patients not treated
Interventions
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Patients not treated
Eligibility Criteria
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Inclusion Criteria
* Farmacological treatment with L-Dopa and/or dopaminergic agonist or diagnosis de novo
* BMI 18.5 - 29.9 kg/m\^2
* Informed consent signature
* Absence of major disease
* BMI 18.5 - 29.9 kg/m\^2
* Informed consent signature
Exclusion Criteria
* Presence of major chronic diseases of the digestive tract.
* Pregnancy in progress
* Subjects subjected to antihypertensive therapies or statins or with drugs that can change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)
* Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid disease)
* Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl
* Presence of chronic liver disease or ALT and AST levels exceeding two standard deviations from normal levels
* Presence of malignant disease
* Alcohol or drug abuse
* Major psychiatric disorders
* Subjects dedicated to intense and agonistic physical activity.
Control group
* Presence of type 1 and type 2 diabetes mellitus
* Presence of major chronic diseases of the digestive tract.
* Pregnancy in progress
* Subjects subjected to antihypertensive therapies or statins or with drugs that can change metabolic status and insulin sensitivity (e.g. chronic oral steroid therapy)
* Subjects affected by endocrine pathologies (e.g. Cushing disease, uncontrolled thyroid disease)
* Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl
* Presence of chronic liver disease or ALT and AST levels exceeding two standard deviations from normal levels
* Presence of malignant disease
* Alcohol or drug abuse
* Major psychiatric disorders
* Subjects dedicated to intense and agonistic physical activity.
18 Years
ALL
Yes
Sponsors
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Istituti Clinici di Perfezionamento di Milano
OTHER
University of Milan
OTHER
Responsible Party
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roberta cazzola
Principal Investigator
Principal Investigators
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Roberta Cazzola, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, , Italy
Countries
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References
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Forsyth CB, Shannon KM, Kordower JH, Voigt RM, Shaikh M, Jaglin JA, Estes JD, Dodiya HB, Keshavarzian A. Increased intestinal permeability correlates with sigmoid mucosa alpha-synuclein staining and endotoxin exposure markers in early Parkinson's disease. PLoS One. 2011;6(12):e28032. doi: 10.1371/journal.pone.0028032. Epub 2011 Dec 1.
Lebouvier T, Chaumette T, Paillusson S, Duyckaerts C, Bruley des Varannes S, Neunlist M, Derkinderen P. The second brain and Parkinson's disease. Eur J Neurosci. 2009 Sep;30(5):735-41. doi: 10.1111/j.1460-9568.2009.06873.x. Epub 2009 Aug 27.
Han R. Plasma lipoproteins are important components of the immune system. Microbiol Immunol. 2010 Apr;54(4):246-53. doi: 10.1111/j.1348-0421.2010.00203.x.
Levels JH, Marquart JA, Abraham PR, van den Ende AE, Molhuizen HO, van Deventer SJ, Meijers JC. Lipopolysaccharide is transferred from high-density to low-density lipoproteins by lipopolysaccharide-binding protein and phospholipid transfer protein. Infect Immun. 2005 Apr;73(4):2321-6. doi: 10.1128/IAI.73.4.2321-2326.2005.
Hughes AJ, Ben-Shlomo Y, Daniel SE, Lees AJ. What features improve the accuracy of clinical diagnosis in Parkinson's disease: a clinicopathologic study. 1992. Neurology. 2001 Nov;57(10 Suppl 3):S34-8. No abstract available.
Other Identifiers
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Unimi
Identifier Type: -
Identifier Source: org_study_id
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