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

17 octobre 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

128

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • France
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

patients suffering of diabetes type 1 or type 2.

La description

Inclusion Criteria:

  • type 1 or 2 diabetes

Exclusion Criteria:

  • atypical diabetes

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Type 1 diabetes
dosing of sphingolipids
Autre: dosing of sphingolipids
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
Type 2 diabetes
Dosing of sphingolipids
Autre: dosing of sphingolipids
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Groupe Hospitalier Pitie-Salpetriere

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 avril 2017

Achèvement primaire (Réel)

16 septembre 2017

Achèvement de l'étude (Réel)

16 septembre 2017

Dates d'inscription aux études

Première soumission

31 janvier 2018

Première soumission répondant aux critères de contrôle qualité

21 février 2018

Première publication (Réel)

27 février 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 octobre 2018

Dernière vérification

1 octobre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CIC14-21-17-12

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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