Gut-derived Neuropeptides in Cerebrospinal Fluid 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.


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.)?

Full Title of Study: “Quantitative Analysis of Gut-derived Neuropeptides in Cerebrospinal Fluid (CSF) of Patients With Parkinson’s Disease and Healthy Controls”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Arms, Groups and Cohorts

  • Parkinson’s disease
    • Patients with Parkinson’s disease
  • Control
    • Healthy controls

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Marcus Unger
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Marcus Unger, Consultant / Oberarzt der Klinik für Neurologie – Saarland University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.