Clinical trial NCT03447964: Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes
Official title: Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: sphingolipids
hepatic steatosis
non-alcoholic fatty liver disease
macrovascular complications
insulin resistance
microvasclar complications
NAFLD
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering of diabetes type 1 or type 2.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* type 1 or 2 diabetes

Exclusion Criteria:

* atypical diabetes

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

Primary outcomes:
measure: Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary outcomes:
measure: - Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - - Comparison of plasma total sphingomyelins concentration in type 2 diabetic patients versus type 1 diabetic patients.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - Comparison of plasma total sphingosine concentration in type 2 diabetic patients versus type 1 diabetic patients.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - 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.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - 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.
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - Correlation between sphingolipids species concentrations and NAFLD biomarkers (steatotest, NASHtest and fibrotest)
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - Correlation between sphingolipids species concentrations and insulin resistance (HOMA-IR)
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - Correlation between sphingolipids species concentrations and microvascular complications (history of retinopathy, nephropathy and neuropathy)
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
measure: - Correlation between sphingolipids species concentrations and macrovascular complications (cardiovascular disease history)
timeFrame: Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
References: