Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

NCT04315038 | Completed

• 1 other identifier: 201801931A
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.

Conditions

Aging; Metabolites; Neurodegenerative Diseases

Keywords

Aging; cerebrospinal fluid; metabolomics

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All patients

Spinal anesthesia

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

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.

All patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with received spinal anesthesia and had written informed consent

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

CSF samples will be stored in aliquots at -80 °C before analysis. The sample will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS) in the Metabolomic Core Laboratory at Chang Gung Memorial Hospital or Chang Gung University. Demographic data including age, gender, body weight, blood pressure and past medical data will be investigated.

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 19, 2020
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: January 31, 2022

Record last verified: 2021-01

Locations

TW (1)