Patients with Parkinson's disease (PD) present an impaired intestinal permeability with consequent lipopolysaccharide (LPS) translocation in the systemic circulation. Plasmatic lipoproteins play a key role in the detoxification of LPS.
The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD.
Condition or disease | Intervention/treatment |
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Parkinson Disease | Other: Patients not treated |
Bacterial lipopolysaccharides are able to produce neuroinflammation and dopaminergic receptors degeneration. In addition, they may produce an accumulation of α-synuclein in the area of the substantia Nigra. Recent studies have shown that α-synuclein aggregates may be present also in gastrointestinal neurons of patients with PD. This last finding led to the hypothesis that the intestine might be an early site of PD disease in response to an environmental toxin or pathogen. Forsyth et al. have discovered an impaired intestinal permeability in subjects with recently diagnosed PD, and they found positive correlations between this factor, exposure to LPS and alpha-synuclein accumulation in gastrointestinal neurons. Plasma lipoproteins play a key role in the detoxification of bacterial endotoxins. Lipoprotein chemical composition is related to their detoxing properties. To the best of investigator knowledge, the relationships between lipoprotein chemical composition and LPS in PD have not yet been investigated. Therefore, the aims of this study are: I) to evaluate the chemical composition of VLDL, LDL and HDL in subjects with PD compared to a control group; 2) to analyze the activity of plasma lipid transfer proteins and LPS plasma levels in the same groups of subjects; III) finally, to investigate the correlations between the analyzed parameters.
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.
Study Type : | Observational |
Actual Enrollment : | 45 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Lipoprotein Lipidic Composition, Lipopolysaccharide Binding Protein, and Bacterial Endotoxin Exposure in Parkinson's Disease: A Pilot Study |
Actual Study Start Date : | May 3, 2016 |
Actual Primary Completion Date : | October 20, 2017 |
Actual Study Completion Date : | October 20, 2017 |
Group/Cohort | Intervention/treatment |
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Parkinson's patients
Patients with Parkinson disease evaluated in agreement with UK Brain Bank criteria
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Other: Patients not treated |
Control group
Subject matched for sex, age and BMI
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Other: Patients not treated |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Parkinson's patients
Inclusion Criteria:
Exclusion criteria:
Control group
Inclusion criteria
Exclusion Criteria:
Italy | |
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | |
Milan, Italy, 20136 |
Principal Investigator: | Roberta Cazzola, PhD | University of Milan |
Tracking Information | |||||
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First Submitted Date | April 16, 2019 | ||||
First Posted Date | May 3, 2019 | ||||
Last Update Posted Date | May 3, 2019 | ||||
Actual Study Start Date | May 3, 2016 | ||||
Actual Primary Completion Date | October 20, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
Plasma lipid transfer proteins [ Time Frame: through study completion an average of 1 year ] Lipopolysaccharide binding protein (ng/mL), cholesterol ester transfer protein (ng/mL), phospholipid transfer protein (ng/mL)
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease | ||||
Official Title | Lipoprotein Lipidic Composition, Lipopolysaccharide Binding Protein, and Bacterial Endotoxin Exposure in Parkinson's Disease: A Pilot Study | ||||
Brief Summary |
Patients with Parkinson's disease (PD) present an impaired intestinal permeability with consequent lipopolysaccharide (LPS) translocation in the systemic circulation. Plasmatic lipoproteins play a key role in the detoxification of LPS. The investigators aim to study the relationships between lipoprotein chemical composition and plasma LPS circulation in PD. |
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Detailed Description |
Bacterial lipopolysaccharides are able to produce neuroinflammation and dopaminergic receptors degeneration. In addition, they may produce an accumulation of α-synuclein in the area of the substantia Nigra. Recent studies have shown that α-synuclein aggregates may be present also in gastrointestinal neurons of patients with PD. This last finding led to the hypothesis that the intestine might be an early site of PD disease in response to an environmental toxin or pathogen. Forsyth et al. have discovered an impaired intestinal permeability in subjects with recently diagnosed PD, and they found positive correlations between this factor, exposure to LPS and alpha-synuclein accumulation in gastrointestinal neurons. Plasma lipoproteins play a key role in the detoxification of bacterial endotoxins. Lipoprotein chemical composition is related to their detoxing properties. To the best of investigator knowledge, the relationships between lipoprotein chemical composition and LPS in PD have not yet been investigated. Therefore, the aims of this study are: I) to evaluate the chemical composition of VLDL, LDL and HDL in subjects with PD compared to a control group; 2) to analyze the activity of plasma lipid transfer proteins and LPS plasma levels in the same groups of subjects; III) finally, to investigate the correlations between the analyzed parameters. 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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
Plasma and erythrocytes
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Sampling Method | Non-Probability Sample | ||||
Study Population | Parkinson affected patients and healthy controls matched for sex, age and BMI in agreement with inclusion criteria. | ||||
Condition | Parkinson Disease | ||||
Intervention | Other: Patients not treated | ||||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
45 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | October 20, 2017 | ||||
Actual Primary Completion Date | October 20, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Parkinson's patients Inclusion Criteria:
Exclusion criteria:
Control group Inclusion criteria
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Italy | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03937284 | ||||
Other Study ID Numbers | Unimi | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | roberta cazzola, University of Milan | ||||
Study Sponsor | University of Milan | ||||
Collaborators | Istituti Clinici di Perfezionamento di Milano | ||||
Investigators |
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PRS Account | University of Milan | ||||
Verification Date | May 2019 |