Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients

Not Applicable

Completed

• Conditions: diabète de Type 1
• Interventions: Biological: Prise de sang

• Registration Number: NCT02816099
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

In type-1 diabetes patients, bad cholesterol tends to accumulate because apoC1 function is slowed down.

ApoC1 is a protein whose role is to diminish the activity of CETP, another protein that regulates cholesterol transfer in the body.

The aim of this study is to determine whether it is possible to correct apoC1 function by improving glycaemic balance.

240 persons will be recruited in this study and allocated to one of two groups:

* 160 Type-1 diabetes patients with uncontrolled diabetes:

* 4 additional blood samples will be taken at the time of the systematic biological examination at inclusion and then again 3 months later.

* 80 control subjects with normal lipids and normal glycaemia balance will be included in the study following the results of the biological assays.

* 4 blood samples will be taken at the time of inclusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-20
• Study First Submitted: 2016-06-24
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria patients:

• Adults under guardianship
• Patients without national health insurance
• Pregnant or breast-feeding women
• Progressive cancer
• Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)

Exclusion criteria controls:

• Adults under guardianship
• Persons without national health insurance
• Pregnant or breast-feeding women
• known dyslipidemia and/or lipid-lowering treatment
• Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type-1 diabetes patients	Prise de sang	-
Controls	Prise de sang	-

Primary Outcome Measures

Name	Time	Method
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity	3 mois

Trial Locations

Locations (2)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

CHU de Besançon; 🇫🇷 Besancon, France