Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

Completed

• Conditions: Aging; Metabolites; Neurodegenerative Diseases
• Interventions: Procedure: spinal anesthesia

• Registration Number: NCT04315038
• Lead Sponsor: Chang Gung Memorial Hospital

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).

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Status Verified: 2021-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Aging groups:

1. . Above 20 years.
2. . No history of central nerve system injury and neurologic illness
3. . ASA≦II
4. . Written informed consent from the patient

Aged-related neurodegenerative diseases group:

1. . Above 60 years of age
2. . Medical record proved the history of Parkinsonism or Alzheimer disease
3. . ASA≦III
4. . Written informed consent from the patient or guardian by statute.

Exclusion Criteria

1. patient refuses to sign informed consent
2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment
3. patients with spine or brain tumor and CNS disease
4. 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
5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	spinal anesthesia	Spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases	An average of 1 year	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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan