Metabolomic Profiling of Cerebrospinal Fluid and Plasma in Patients With type2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]
研究概览
简要总结
To exam the metabolomic profiling of CSF and plasma in diabetes and establish the human CSF Metabolome Database of Type 2 DM.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Find the reliable biomarkers, using metabolomic analysis [NMR, LC-MS]
时间窗: 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.
Exam metabolic profiles of CSF and plasma in diabetes. (Metabolites analysis of CSF and plasma)
时间窗: 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.
次要结局
未报告次要终点