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

17. oktober 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

128

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. april 2017

Primær fullføring (Faktiske)

16. september 2017

Studiet fullført (Faktiske)

16. september 2017

Datoer for studieregistrering

Først innsendt

31. januar 2018

Først innsendt som oppfylte QC-kriteriene

21. februar 2018

Først lagt ut (Faktiske)

27. februar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIC14-21-17-12

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