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临床试验/NCT03447964
NCT03447964已完成不适用

Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes

Groupe Hospitalier Pitie-Salpetriere1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 1 or 2 diabetes

排除标准

  • atypical diabetes
  • family dyslipidemia
  • nonmetabolic hepatopathy
  • severe renal failure
  • corticosteroid or immunosuppressive therapy

结局指标

主要结局

Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

时间窗: 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).

次要结局

  • - Correlation between sphingolipids species concentrations and NAFLD biomarkers (steatotest, NASHtest and fibrotest)(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)(Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day)
  • - Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.(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.(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.(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.(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.(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)(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)(Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day)

研究者

发起方
Groupe Hospitalier Pitie-Salpetriere
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Groupe Hospitalier Pitie-Salpetriere

研究点 (1)

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