Metabolomic Profiling of in Patients With type2 Diabetes

Study Overview
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Brief Summary
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To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.

Detailed Description
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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.

Official Title
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Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes

Conditions
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Diagnoses Disease, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: spinal anesthesia


Participation Criteria
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Eligibility Criteria
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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) -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>spinal anesthesia | Procedure: spinal anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS] | 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. | Through study completion, an average of 1 year | 
| Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma) | 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. | Through study completion, an average of 1 year |