Clinical trial NCT02816099: Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients
Official title: Study of the Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesterol Ester Transfer Protein (CETP) in Type-1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: diabète de Type 1
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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)

Primary outcomes:
measure: Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
timeFrame: 3 mois
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besançon
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
citation: Denimal D, Monier S, Simoneau I, Duvillard L, Verges B, Bouillet B. HDL functionality in type 1 diabetes: enhancement of cholesterol efflux capacity in relationship with decreased HDL carbamylation after improvement of glycemic control. Cardiovasc Diabetol. 2022 Aug 12;21(1):154. doi: 10.1186/s12933-022-01591-9.