NCT03447964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

January 31, 2018

Last Update Submit

October 17, 2018

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1

Keywords

sphingolipidshepatic steatosisnon-alcoholic fatty liver diseasemacrovascular complicationsinsulin resistancemicrovasclar complicationsNAFLD

Outcome Measures

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).

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

Secondary Outcomes (9)

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

    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.

    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.

    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.

    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.

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

  • +4 more secondary outcomes

Study Arms (2)

Type 1 diabetes

dosing of sphingolipids

Other: dosing of sphingolipids

Type 2 diabetes

Dosing of sphingolipids

Other: dosing of sphingolipids

Interventions

dosing of sphingolipidsOTHER

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

Type 1 diabetesType 2 diabetes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients suffering of diabetes type 1 or type 2.

You may qualify if:

  • type 1 or 2 diabetes

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples and dosing of Sphingolipids

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1Fatty LiverNon-alcoholic Fatty Liver DiseaseInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesLiver DiseasesDigestive System DiseasesHyperinsulinism

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant director, clinical investigation center Paris Est

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 27, 2018

Study Start

April 4, 2017

Primary Completion

September 16, 2017

Study Completion

September 16, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

FR(1)