- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03447964
Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes (CERADIAB)
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Paris, Франция, 75013
- Groupe Hospitalier Pitie-Salpetriere
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- type 1 or 2 diabetes
Exclusion Criteria:
atypical diabetes
- family dyslipidemia
- nonmetabolic hepatopathy
- severe renal failure
- corticosteroid or immunosuppressive therapy
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
---|---|
Type 1 diabetes
dosing of sphingolipids
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- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
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Type 2 diabetes
Dosing of sphingolipids
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- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CIC14-21-17-12
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
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