Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

NCT ID: NCT04315038

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Aging Metabolites Neurodegenerative Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Spinal anesthesia

spinal anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201801931A

Identifier Type: -

Identifier Source: org_study_id

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