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Completed

NCT Number: NCT04315038

Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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