Metabolomic Profiling of in Patients With type2 Diabetes
January 29, 2020 updated by: Chang Gung Memorial Hospital
Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes
To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Human cerebral spinal fluid (CSF) is known to be a rich source of small molecule biomarkers for central neurological and neurodegenerative diseases.
However, the metaboloic bases of CSF in diabetes patient have not been studied.
In this plan, the investigators will use analytical platforms, including nuclear magnetic resonance (NMR), liquid chromatography-mass spectrometry (LC-MS), to perform quantitative metabolomics on human CSF and blood samples and further establish the human CSF Metabolome Database of DM.
This work will can supply important CSF metabolic profit information and help to facilitate a wide range of metabolomic studies on central nervous system diseases and their associations disease.
Study Type
Observational
Enrollment (Actual)
68
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
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
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:
Diabetes group
- .20-75 years of age
- .Type 2 diabetes patient by clinical diagnosis
- .American Association of Anesthesiologists (ASA)≦III
Control group (non-diabetic group):
- .20-75 years of age
- .No history of DM and other systemic illness
- .American Association of Anesthesiologists (ASA)≦ II
Exclusion Criteria:
- 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 severe CNS disease.
- the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study other than DM which could compromise participation in the 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)
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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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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All patients
spinal anesthesia
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Plan to enroll 120 Type 2 diabetes and 120 non-diabetes 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]
Time Frame: Through study completion, an average of 1 year
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Use metabolomic analysis to connect CSF and blood metabolomic profiles information for further clarification of the influence of DM in CNS and expect to find new reliable biomarkers in diabetes patient for early predict DM progression and outcome.
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Through study completion, an average of 1 year
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Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma)
Time Frame: Through study completion, an average of 1 year
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Metabolites analysis of CSF and plasma 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.
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Through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2016
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
September 27, 2018
First Submitted That Met QC Criteria
October 30, 2018
First Posted (Actual)
October 31, 2018
Study Record Updates
Last Update Posted (Actual)
January 31, 2020
Last Update Submitted That Met QC Criteria
January 29, 2020
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140-9207A
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.