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

May 2, 2019 updated by: roberta cazzola, University of Milan

Lipoprotein Lipidic Composition, Lipopolysaccharide Binding Protein, and Bacterial Endotoxin Exposure in Parkinson's Disease: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20136
        • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LPS
Time Frame: through study completion an average of 1 year
LPS plasma levels (EU/L)
through study completion an average of 1 year
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
through study completion an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

Istituti Clinici di Perfezionamento di Milano

Investigators

  • Principal Investigator: Roberta Cazzola, PhD, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 3, 2016

Primary Completion (ACTUAL)

October 20, 2017

Study Completion (ACTUAL)

October 20, 2017

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

May 2, 2019

First Posted (ACTUAL)

May 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Unimi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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