Metabolomic Profiling of in Patients With type2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725709
• Other study ID #: 140-9207A
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

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Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diagnoses Disease

Intervention

Procedure:
• spinal anesthesia
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.

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	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
Primary	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