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NCT Number: NCT03725709

Metabolomic Profiling of in Patients With type2 Diabetes

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

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diabetes group

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

Control group (non-diabetic group):

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

Exclusion criteria

  • patient refuses to sign informed consent
  • patients with coagulopathy, systemic infective disease and severe liver and renal function impairment.
  • patients with spine or brain tumor and severe CNS disease.
  • 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.
  • Concurrent participation or planning to participate in another interventional clinical trial (Concurrent participation in an observational trial allowed)

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Treatment and study plan

Spinal anesthesia

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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