Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315038
• Other study ID #: 201801931A
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Metabolites
• Neurodegenerative Diseases

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases	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