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

Diabetes Mellitus, Type 2 Clinical Trial

— CERADIAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447964
• Other study ID #: CIC14-21-17-12
• Status: Completed
• Start date: April 4, 2017
• Est. completion date: September 16, 2017

Study information

• Verified date: October 2018
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 16, 2017
• Est. primary completion date: September 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• type 1 or 2 diabetes

Exclusion Criteria:

• atypical diabetes

• family dyslipidemia

• nonmetabolic hepatopathy

• severe renal failure

• corticosteroid or immunosuppressive therapy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Fatty Liver

Intervention

Other:
• dosing of sphingolipids
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine

Locations

Country	Name	City	State
France	Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- - 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day
Secondary	- 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).	Samples taken in 1 single time in the morning, patients fast for 12 hours, on 1 single day