Metabolomic Profiling of in Patients With type2 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 2; Diagnoses Disease
• Interventions: Procedure: spinal anesthesia

• Registration Number: NCT03725709
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-08-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Diabetes group

1. .20-75 years of age
2. .Type 2 diabetes patient by clinical diagnosis
3. .American Association of Anesthesiologists (ASA)≦III

Control group (non-diabetic group):

1. .20-75 years of age
2. .No history of DM and other systemic illness
3. .American Association of Anesthesiologists (ASA)≦ II

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 severe CNS disease.

4. 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.

5. Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	spinal anesthesia	spinal anesthesia

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan