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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725709
Other study ID # 140-9207A
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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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Study Design


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
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