Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04315038
Collaborator
(none)
190
1
24
7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: spinal anesthesia

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 Design

Study Type:
Observational
Actual Enrollment :
190 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Metabolomics Profiling and Biomarker Research of Human Cerebrospinal Fluid in Aging Process and Age-related Neurodegenerative Diseases
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
All patients

Spinal anesthesia

Procedure: spinal 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Taoyuan Taiwan 333

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT04315038
Other Study ID Numbers:
  • 201801931A
First Posted:
Mar 19, 2020
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022