Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes
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 |
Verified date | September 2018 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.
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) - |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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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