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Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04315038
Enrollment
190
Registered
2020-03-19
Start date
2019-08-01
Completion date
2021-07-31
Last updated
2022-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Metabolites, Neurodegenerative Diseases

Keywords

Aging, cerebrospinal fluid, metabolomics

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).

Interventions

PROCEDUREspinal anesthesia

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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseasesAn average of 1 yearMetabolites 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026