Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With

Status Completed

Clinical Trial Summary

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.)?

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01792193
Study type	Observational
Source	Saarland University
Contact
Status	Completed
Phase	N/A
Start date	January 2013
Completion date	December 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms