Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

January 28, 2022 updated by: Chang Gung Memorial Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with received spinal anesthesia and had written informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 28, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801931A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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