Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

Study Overview
=================
Brief Summary
-----------------
Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.

Detailed Description
-----------------
Metabolomics is new science based on metabolite profiles in biofluids and tissues, which under bioinformatics approaches and analyses could help to characterize metabolomic status of CSF in aging process. In this prospective study, the investigators plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received operation under spinal anesthesia. Blood and CSF samples will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS).

Official Title
-----------------
Metabolomics Profiling and Biomarker Research of Human Cerebrospinal Fluid in Aging Process and Age-related Neurodegenerative Diseases

Conditions
-----------------
Aging, Metabolites, Neurodegenerative Diseases

Intervention / Treatment
-----------------
* Procedure: spinal anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aging groups: . Above 20 years. . No history of central nerve system injury and neurologic illness . ASA≦II . Written informed consent from the patient Aged-related neurodegenerative diseases group: . Above 60 years of age . Medical record proved the history of Parkinsonism or Alzheimer disease . ASA≦III . Written informed consent from the patient or guardian by statute. Exclusion Criteria: patient refuses to sign informed consent patients with coagulopathy, systemic infective disease and severe liver and renal function impairment patients with spine or brain tumor and CNS disease the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Spinal anesthesia | Procedure: spinal anesthesia<br>* Plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received spinal anesthesia. Blood will be collected at time point of pre-anesthesia 10 minutes and CSF samples will be collected at time point during spinal anesthesia induction. Blood will be collected, drawn into EDTA-coated tube.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases | Metabolites analysis of CSF will be investigated by NMR, LC-MS. Peak lists of all NMR and LC/MS/MS spectra will be searched against the database through a web server for metabolomic data analysis and further establish the CSF Metabolome Database. | An average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aging, cerebrospinal fluid, metabolomics