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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease

Clinicaltrials.gov identifier NCT03937284

Recruitment Status Completed

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

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:Parkinson Disease
  • Intervention/Treatment: Other: Patients not treated
  • Phase: N/A
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 Design
  • 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 2016
  • Actual Primary Completion Date: October 2017
  • Actual Study Completion Date: October 2017
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Control group
Subject matched for sex, age and BMI
Other: Patients not treated
: Parkinson's patients
Patients with Parkinson disease evaluated in agreement with UK Brain Bank criteria
Other: Patients not treated
Outcome Measures
  • 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

Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations

Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan

Sponsors and Collaborators

University of Milan

Istituti Clinici di Perfezionamento di Milano

Investigators

Principal Investigator: Roberta Cazzola, PhD University of Milan

More Information