Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients (ApoC1)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: diabète de Type 1

Treatments: Biological: Prise de sang

Study type: Interventional

Funder types: Other

Identifiers

NCT02816099

BOUILLET AOI 2015

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for patients:

• Patients over 18 years
• Patients with type-1 diabetes and glycated hemoglobin (HbA1C) >9%

Inclusion criteria controls:

• Subjects over 18 years
• Normal glycaemia (Fasting glycaemia <1.10 g/L) and normal lipids (Low-density lipoproteins (LDL) <1.6 g/L, triglycerides (TG) <1.5 g/L)

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Type-1 diabetes patients

Experimental group

Treatment:

Biological: Prise de sang

Controls

Other group

Treatment:

Biological: Prise de sang