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

NCT ID: NCT03447964

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2017-09-16

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 diabetes

dosing of sphingolipids

dosing of sphingolipids

Intervention Type OTHER

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

Type 2 diabetes

Dosing of sphingolipids

dosing of sphingolipids

Intervention Type OTHER

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

Interventions

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dosing of sphingolipids

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* type 1 or 2 diabetes

Exclusion Criteria

* atypical diabetes

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CIC14-21-17-12

Identifier Type: -

Identifier Source: org_study_id

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