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

17. oktober 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

128

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients suffering of diabetes type 1 or type 2.

Beskrivelse

Inclusion Criteria:

  • type 1 or 2 diabetes

Exclusion Criteria:

  • atypical diabetes

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Type 1 diabetes
dosing of sphingolipids
Andet: dosing of sphingolipids
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
Type 2 diabetes
Dosing of sphingolipids
Andet: dosing of sphingolipids
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. april 2017

Primær færdiggørelse (Faktiske)

16. september 2017

Studieafslutning (Faktiske)

16. september 2017

Datoer for studieregistrering

Først indsendt

31. januar 2018

Først indsendt, der opfyldte QC-kriterier

21. februar 2018

Først opslået (Faktiske)

27. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CIC14-21-17-12

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