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

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

Patrocinadores

Patrocinador principal: Dr. Marcus Unger

Fuente Saarland University
Resumen breve

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.)?

Estado general Completed
Fecha de inicio January 2013
Fecha de Terminación December 2015
Fecha de finalización primaria December 2015
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
CSF and serum concentration of ghrelin, leptin, GIP, GLP-1, amylin, PP, PYY, and insulin 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.
Inscripción 40
Condición
Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 75 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Ubicación
Instalaciones: Saarland University
Ubicacion Paises

Germany

Fecha de verificación

March 2016

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: Saarland University

Nombre completo del investigador: Dr. Marcus Unger

Título del investigador: Consultant / Oberarzt der Klinik für Neurologie

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Parkinson's disease

Descripción: Patients with Parkinson's disease

Etiqueta: Control

Descripción: Healthy controls

Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov