Metabolomic Profiling of in Patients With type2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03725709
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : November 2, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Diagnoses Disease Diabetes Mellitus, Type 2 Procedure: spinal anesthesia

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 Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
All patients
spinal anesthesia
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.

Primary Outcome Measures :
  1. Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS] [ Time Frame: 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.

  2. Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma) [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Blood will be centrifuged for 10 min at 4 °C and 4000 rpm. The supernatant (plasma) samples will be stored in aliquots at −80 °C until analysis. CSF samples will be stored in aliquots at −80 °C before analysis. The sample will be analyzed using hydrogen-1 nuclear magnetic resonance (1H-NMR) and lipid chromatography-mass spectrometry (LC-MS) in the Metabolomic Core Laboratory at Chang Gung Memorial Hospital or Chang Gung University. Demographic data including age, gender, body weight, blood pressure and past medical data will be investigated. Blood HbA1c, blood/CSF glucose and insulin level also will be measured.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with received spinal anesthesia and had written informed consent

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03725709

Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Fu Chao Liu, MD,PHD    +886 975365718   
Sponsors and Collaborators
Chang Gung Memorial Hospital

Responsible Party: Chang Gung Memorial Hospital Identifier: NCT03725709     History of Changes
Other Study ID Numbers: 140-9207A
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs