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

diabète de Type 1 Clinical Trial

— ApoC1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816099
• Other study ID #: BOUILLET AOI 2015
• Status: Completed
• Phase: N/A
• Start date: November 20, 2014
• Est. completion date: November 14, 2022

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• diabète de Type 1
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Prise de sang

Locations

Country	Name	City	State
France	CHU de Besançon	Besancon
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity		3 mois