- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03447964
Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes (CERADIAB)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75013
- Groupe Hospitalier Pitie-Salpetriere
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- type 1 or 2 diabetes
Exclusion Criteria:
atypical diabetes
- family dyslipidemia
- nonmetabolic hepatopathy
- severe renal failure
- corticosteroid or immunosuppressive therapy
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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
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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
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
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Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
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- 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.
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CIC14-21-17-12
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