Lipoprotein Metabolism and Bacterial Lipopolysaccharide in Parkinson's Disease

NCT03937284 | Completed

• 1 other identifier: Unimi
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Lipoproteins; Lipopolysaccharide; Lipopolysaccharide binding protein; Inflammation

Outcome Measures

Primary Outcomes (2)

• LPS

  LPS plasma levels (EU/L)

  through study completion an average of 1 year

• Lipoprotein chemical composition

  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 Outcomes (1)

• Plasma lipid transfer proteins

  through study completion an average of 1 year

Study Arms (2)

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

Interventions

Patients not treated OTHER

Control group; Parkinson's patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Milan: lead
• Istituti Clinici di Perfezionamento di Milano: collaborator

Study Sites (1)

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, 20136, Italy

Location

Related Publications (5)

• 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.

  PMID: 22145021 BACKGROUND

• 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.

  PMID: 19712093 BACKGROUND

• 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.

  PMID: 20377753 BACKGROUND

• 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.

  PMID: 15784577 BACKGROUND

• 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.

  PMID: 11775598 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and erythrocytes

MeSH Terms

Conditions

Parkinson Disease; Inflammation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberta Cazzola, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 3, 2019
• Study Start: May 3, 2016
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

IT (1)