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Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease (LiMBaLiP)

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ClinicalTrials.gov Identifier: NCT03937284
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Istituti Clinici di Perfezionamento di Milano
Information provided by (Responsible Party):
roberta cazzola, University of Milan

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.


Condition or disease Intervention/treatment
Parkinson Disease Other: Patients not treated

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
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson's patients
Patients with Parkinson disease evaluated in agreement with UK Brain Bank criteria
Other: Patients not treated
Control group
Subject matched for sex, age and BMI
Other: Patients not treated



Primary Outcome Measures :
  1. LPS [ Time Frame: through study completion an average of 1 year ]
    LPS plasma levels (EU/L)

  2. Lipoprotein chemical composition [ Time Frame: through study completion an average of 1 year ]
    Cholesterol (mg/dL); HDL-cholesterol (mg/dL); triglycerides (mg/dL); phospholipids (mg/dL), apoproteins (mg/dL) of VLDL, LDL and HDL


Secondary Outcome Measures :
  1. 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)


Biospecimen Retention:   Samples Without DNA
Plasma and erythrocytes


Information from the National Library of Medicine

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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
Study Population
Parkinson affected patients and healthy controls matched for sex, age and BMI in agreement with inclusion criteria.
Criteria

Parkinson's patients

Inclusion Criteria:

  • Diagnosis of Parkinson disease in agreement with UK Brain Bank
  • Farmacological treatment with L-Dopa and/or dopaminergic agonist or diagnosis de novo
  • BMI 18.5 - 29.9 kg/m^2
  • Informed consent signature

Exclusion criteria:

  • 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.

Control group

Inclusion criteria

  • Absence of major disease
  • BMI 18.5 - 29.9 kg/m^2
  • Informed consent signature

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937284


Locations
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Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Italy, 20136
Sponsors and Collaborators
University of Milan
Istituti Clinici di Perfezionamento di Milano
Investigators
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Principal Investigator: Roberta Cazzola, PhD University of Milan
Publications:
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Responsible Party: roberta cazzola, Principal Investigator, University of Milan
ClinicalTrials.gov Identifier: NCT03937284    
Other Study ID Numbers: Unimi
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by roberta cazzola, University of Milan:
Lipoproteins
Lipopolysaccharide
Lipopolysaccharide binding protein
Inflammation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases