- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447964
Plasma Dihydroceramides Are Associated With Hepatic Steatosis in Type 1 and Type 2 Diabetes (CERADIAB)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Paris, France, 75013
- Groupe Hospitalier Pitie-Salpetriere
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- type 1 or 2 diabetes
Exclusion Criteria:
atypical diabetes
- family dyslipidemia
- nonmetabolic hepatopathy
- severe renal failure
- corticosteroid or immunosuppressive therapy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 1 diabetes
dosing of sphingolipids
|
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
Type 2 diabetes
Dosing of sphingolipids
|
- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of plasma total ceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Comparison of plasma total dihydroceramides concentration in type 2 diabetic patients versus type 1 diabetic patients.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIC14-21-17-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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