Serum Sphingolipidomic Analyses in Healthy, Diabetic and Prediabetic Subjects
Comparison of Serum Sphingolipidomic Analyses in Healthy, Pre-diabetic and Diabetic Subjects
研究概览
详细说明
The first purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the weight among type 2 diabetes. 60 patients with diagnosed type 2 diabetes will be recruited. The serum concentrations of sphingolipid metabolites of 20 type 2 diabetic patients with obesity will be compared to age- and sex-matched series of 40 type 2 patients without obesity.
The second purpose of this study is to determine whether serum sphingolipid metabolites associate significantly with the process and severity of type 2 diabetes. The serum concentrations of sphingolipid metabolites of 20 subjects with type 2 diabetes will be compared to age-, sex- and BMI-matched series of healthy and pre-diabetic subjects. Investigators speculate that the serum concentration of sphingolipid metabolites are positively related with the progression of diabetes. In order to discover why serum sphingolipid metabolites correlates with the progression of diabetes, detailed information on HbA1c, duration of diabetes history and insulin resistance defined by homeostatic model assessment (HOMA-IR) will be analysed. These three parameters may affect the serum concentrations of sphingolipid metabolites.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710061
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
subjects undergoing oral glucose tolerance test and hospitalized type 2 diabetic patients in the Dpartment of Endocrinology in the First Affiliated Hospital of Xi'an Jiaotong Unversity are collected.
healthy subjects undergoing routine physical exam in the department of medical examination center, First Affiliated Hospital of Xi'an Jiaotong Unversity are recruited
描述
Inclusion Criteria:
- clinical diagnosis of diabetes mellitus, type 2
- clinical diagnosis of prediabetic status
- older than 18 and younger than 90 years-old
- clinical diagnosis of insulin-resistance
- clinical diagnosis of newly onset of diabetes mellitus, type 2
- those who are willing to participate in the trial and sign the consent form
Exclusion Criteria:
- any cardiovascular disease (myocardial infarction, heart failure, cerebrovascular accident)
- missing information of BMI
- sever liver, kidney dysfunction
- sever pancreatitis or those who received pancreatectomy
- on medications of hormone, immunosuppressive therapy or drugs that may affect the bioactivity or concentration of sphingolipids (e.g. asprin )
- patients on pregnancy
- sever systematic diseases including carcinoma, mental disorder, sever anemia et al.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
serum sphingolipid metabolites in healthy subjects
Healthy subjects are classified according to BMI into three subgroups: healthy normal weight subjects, healthy overweight subjects and healthy subjects with obesity.
Age and sex are matched among three subgroups.
serum sphingolipid metabolites including sphingosine-1-phosphate will be compared.
|
|
|
serum sphingolipid metabolites in diabetic subjects
Diagnosed diabetic patients are divided into three subgroups: diabetic patients with normal weight, overweight and obesity.
age and sex are matched.
|
the exposure of interests are obesity, diabetes and insulin-resistance
其他名称：
|
|
serum sphingolipid metabolites in the progression of diabetes
serum sphingolipid metabolites are compared among three age-, sex- and body mass index-matched subgroups: healthy subjects, subjects with pre-diabetes, subjects with diabetes
|
the exposure of interests are obesity, diabetes and insulin-resistance
其他名称：
|
|
serum sphingolipid metabolites and HbA1c
diabetic subjects are divided by HbA1c level.
the cut-offs are 7% and 9%.
serum sphingolipid metabolites will be tested among diabetic patients with HbA1c <7%, 7%-9% and >9%
|
the exposure of interests are obesity, diabetes and insulin-resistance
其他名称：
|
|
serum sphingolipid metabolites in insulin-resistant subjects
comparison of serum sphingolipid metabolites in newly diagnosed insulin-resistant subjects and age-, sex- and BMI-matched healthy controls.
|
the exposure of interests are obesity, diabetes and insulin-resistance
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
serum concentration of sphingosine-1-phosphate, micromol per liter
大体时间：Nov, 2016
|
Nov, 2016
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
serum concentration of sphingosine, micromol per liter
大体时间：Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine-1-phosphate, micromol per liter
大体时间：Nov, 2016
|
Nov, 2016
|
|
serum concentration of sphinganine, micromol per liter
大体时间：Nov, 2016
|
Nov, 2016
|
|
serum concentration of ceramide, micromol per liter
大体时间：Nov, 2016
|
Nov, 2016
|
合作者和调查者
调查人员
- 研究主任：Jing Sui、First Affiliated Hospital Xi'an Jiaotong University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.