Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes (CERADIAB)
2018年10月17日 更新者：Joe Elie Salem、Groupe Hospitalier Pitie-Salpetriere
Sphingolipids are associated with metabolic diseases.
Distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied.
The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.
研究概览
详细说明
Sphingolipids represent a major class of lipids that are structural and signaling molecules. Major bioactive sphingolipids include ceramide, dihydroceramide, sphingosine, sphingosine-1-phosphate and sphingomyelin.
Sphingoliplids are involved in development of various chronic metabolic diseases. Some ceramides species are implicated in pancreatic β-cell apoptosis and in insulin resistance in muscle, fat and liver. Some studies have shown association between inhibition of ceramide synthesis, insulin sensibility and lower hepatic steatosis. The deposition of hepatic lipids, especially triacylglycerol, defines the development of hepatic steatosis. However, sphingolipids appear to play an important role in non-alcoholic fatty liver disease (NAFLD) and in its progression. Changes in plasma shingolipids concentrations may also contribute to the pathogenesis in cardiovascular disease and atherosclerosis. Distribution of plasma sphingolipids concentrations in type 1 and type 2 diabetes has poorly been studied.
The objective of the CERADIAB study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.
研究类型
观察性的
注册 (实际的)
128
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Paris、法国、75013
- Groupe Hospitalier Pitie-Salpetriere
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients suffering of diabetes type 1 or type 2.
描述
Inclusion Criteria:
- type 1 or 2 diabetes
Exclusion Criteria:
atypical diabetes
- family dyslipidemia
- nonmetabolic hepatopathy
- severe renal failure
- corticosteroid or immunosuppressive therapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
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Type 1 diabetes
dosing of sphingolipids
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- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
|
Type 2 diabetes
Dosing of sphingolipids
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- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- - Comparison of plasma total sphingomyelins concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Comparison of plasma total sphingosine concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Comparison of plasma ceramide species (C16, C18, C20, C22, C23, C24, C24:1, C26:1, C26:2 ceramides) concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Comparison of plasma dihydroceramide species (C18/16, C18/18, C18/20, C18/22, C18/23, C18/24, C18/24:1, C18/26:1, C18/26:2 dihydroceramides) concentration in type 2 diabetic patients versus type 1 diabetic patients.
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Correlation between sphingolipids species concentrations and NAFLD biomarkers (steatotest, NASHtest and fibrotest)
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Correlation between sphingolipids species concentrations and insulin resistance (HOMA-IR)
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Correlation between sphingolipids species concentrations and microvascular complications (history of retinopathy, nephropathy and neuropathy)
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
|
- Correlation between sphingolipids species concentrations and macrovascular complications (cardiovascular disease history)
大体时间：Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
Three-hundred microlitres of plasma were used to quantify dihydroceramides, ceramides, sphingomyelins and sphingosine content.
The lipid subspecies were extracted and analysed by Liquid Chromatography Mass Spectrometry (LC-MS/MS), at the Lipidomic Core Facility of the University of Bourgogne (Dijon, France).
|
Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年4月4日
初级完成 (实际的)
2017年9月16日
研究完成 (实际的)
2017年9月16日
研究注册日期
首次提交
2018年1月31日
首先提交符合 QC 标准的
2018年2月21日
首次发布 (实际的)
2018年2月27日
研究记录更新
最后更新发布 (实际的)
2018年10月18日
上次提交的符合 QC 标准的更新
2018年10月17日
最后验证
2018年10月1日
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.
dosing of sphingolipids的临床试验
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University of Stellenbosch完全的
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Compedica IncProfessional Education and Research Institute招聘中
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Bionano GenomicsColumbia University; University of Iowa; Medical College of Wisconsin; Augusta University; University... 和其他合作者招聘中
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The University of Texas Health Science Center,...Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive and Kidney...完全的
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Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development未知
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Oregon Health and Science University未知