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

NCT01792193 | Completed

• 1 other identifier: Studie 139/12
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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:
• Do CSF (and serum) concentrations of these gut peptides differ between PD patients and controls?
• 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.)?

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• CSF and serum concentration of ghrelin, leptin, GIP, GLP-1, amylin, PP, PYY, and insulin

  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.

Study Arms (2)

Parkinson's disease

Patients with Parkinson's disease

Control

Healthy controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Marcus Unger: lead

Study Sites (1)

Saarland University

Homburg / Saar, Saarland, 66421, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF and serum samples

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant / Oberarzt der Klinik für Neurologie

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 15, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

DE (1)