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CompletedNCT03447964CERADIABUpdated Oct 18, 2018

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

An observational study in Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-18.

Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
128
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1

Keywords

  • sphingolipids
  • hepatic steatosis
  • non-alcoholic fatty liver disease
  • macrovascular complications
  • insulin resistance
  • microvasclar complications
  • NAFLD
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients suffering of diabetes type 1 or type 2.

Inclusion criteria

  • type 1 or 2 diabetes

Exclusion criteria

Exclusion Criteria:

  • atypical diabetes

    • family dyslipidemia
    • nonmetabolic hepatopathy
    • severe renal failure
    • corticosteroid or immunosuppressive therapy
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
128 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Type 1 diabetes

    dosing of sphingolipids

    Other: dosing of sphingolipids

  • Type 2 diabetes

    Dosing of sphingolipids

    Other: dosing of sphingolipids

Interventions

  • Otherdosing of sphingolipids

    - Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine

05

What researchers measure

Primary outcomes

  1. Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

Secondary outcomes

  1. - Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  2. - - Comparison of plasma total sphingomyelins concentration in type 2 diabetic patients versus type 1 diabetic patients.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  3. - Comparison of plasma total sphingosine concentration in type 2 diabetic patients versus type 1 diabetic patients.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  4. - 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.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  5. - 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.

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  6. - Correlation between sphingolipids species concentrations and NAFLD biomarkers (steatotest, NASHtest and fibrotest)

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  7. - Correlation between sphingolipids species concentrations and insulin resistance (HOMA-IR)

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  8. - Correlation between sphingolipids species concentrations and microvascular complications (history of retinopathy, nephropathy and neuropathy)

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

  9. - Correlation between sphingolipids species concentrations and macrovascular complications (cardiovascular disease history)

    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).

    Time frame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day

06

Study locations

1 site
  • Groupe Hospitalier Pitié-Salpêtrière
    Paris, 75013, France
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447964
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Joe Elie Salem (Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere) — Principal investigator
First posted
Feb 27, 2018
Start date
Apr 4, 2017
Primary completion
Sep 16, 2017
Completion
Sep 16, 2017
Last update
Oct 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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