Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls

March 16, 2016 updated by: Dr. Marcus Unger

Quantitative Analysis of Gut-derived Neuropeptides in Cerebrospinal Fluid (CSF) of Patients With Parkinson's Disease and Healthy Controls

In previous work, the investigators analyzed the concentration of gut-derived peptides (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD). The investigators have shown that the secretion pattern differs between PD patients and controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g. Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is based on the following considerations:

  • Receptors for gut-derived peptides are expressed in Central Nervous System (CNS) structures that are affected by the neurodegenerative process underlying Parkinson's disease
  • Gut-derived peptides are involved in the modulation of higher brain functions (mood, cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.
  • The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional in Parkinson's disease.
  • Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able to prevent cell death in neurodegenerative disorders, including Parkinson's disease.

Objective:

Collection of CSF and serum samples in a standardized way in order to quantitatively measure the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:

  1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls?
  2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical and / or epidemiological characteristics of the investigated subjects (age, gender, BMI, disease duration, severity of motor impairments, presence of non-motor symptoms, co-morbidities, medication, etc.)?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

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

  • Germany
    • Saarland
      • Homburg / Saar, Saarland, Germany, 66421
        • Saarland University

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

Main Inclusion Criteria:

  • Informed consent to participate
  • Capability to understand risks of study-related procedures
  • For PD cohort: diagnosis of (idiopathic) Parkinson's disease

Main Exclusion Criteria:

  • Pregnancy
  • Subjects incompetent to provide informed consent
  • Subjects that cannot undergo a lumbar puncture for medical reasons (thrombocytopenia, anticoagulation, increased cranial pressure)
  • For control cohort: presence of a neurodegenerative disorder

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Control
Healthy controls
Parkinson's disease
Patients with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF and serum concentration of ghrelin, leptin, GIP, GLP-1, amylin, PP, PYY, and insulin
Time Frame: The outcome measure will be assessed only once, after an overnight fast between 7 and 8 AM. Study-related procedure will be performed on one singel day. There will be no follow-up.
CSF and corresponding serum samples will be collected in the fasting state in the morning. A standardized collection of the samples is crucial to avoid potential confounders (daytime, metabolic state, etc.). Samples will be frozen immediately and kept at minus 20°C until analysis. Samples will be analysed using a multiplex approach.
The outcome measure will be assessed only once, after an overnight fast between 7 and 8 AM. Study-related procedure will be performed on one singel day. There will be no follow-up.

Collaborators and Investigators

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

Sponsor

Dr. Marcus Unger

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

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Studie 139/12

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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