- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03447964
Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes (CERADIAB)
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Paris, Francie, 75013
- Groupe Hospitalier Pitie-Salpetriere
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- type 1 or 2 diabetes
Exclusion Criteria:
atypical diabetes
- family dyslipidemia
- nonmetabolic hepatopathy
- severe renal failure
- corticosteroid or immunosuppressive therapy
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Type 1 diabetes
dosing of sphingolipids
|
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
Type 2 diabetes
Dosing of sphingolipids
|
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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