AgingNCT04315038
Metabolomics Profiling Research of Human Cerebrospinal Fluid in Aging Process
An observational study of Aging and Metabolites, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Metabolites, Neurodegenerative Diseases
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 190 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with received spinal anesthesia and had written informed consent
Who may be able to join
- 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:
Show all 10Show fewer
- . 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Aging, Metabolites, Neurodegenerative Diseases
- Being tested
- spinal anesthesia
- Keywords
- Aging, cerebrospinal fluid, metabolomics
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Spinal anesthesia Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Aug 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315038
- Sponsor's protocol ID
- 201801931A
- Status last verified
- Jan 2021
- First submitted
- 13 Mar 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics Profiling and Biomarker Research of Human Cerebrospinal Fluid in Aging Process and Age-related Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT04315038
- Acronym / sponsor ID
- 201801931A
- Conditions
- Aging, Metabolites, Neurodegenerative Diseases
- Keywords
- Aging, cerebrospinal fluid, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perform quantitative metabolomics on human cerebrospinal fluid (CSF) samples and establish the first human CSF Metabolome Database of aging process in Taiwan.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: spinal anesthesiaSpinal anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with received spinal anesthesia and had written informed consent
Key inclusion criteria (10 listed)
- . Above 20 years.
- . No history of central nerve system injury and neurologic illness
- . ASA≦II
- . Written informed consent from the patient
- . Above 60 years of age
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaPlan 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. | Procedure or surgery | All patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Metabolites, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exam metabolic profiles of CSF in aging process and age-related neurodegenerative diseases (time frame: An average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.