Clinical trial

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

Name
BOUILLET AOI 2015
Description
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.
Trial arms
Trial start
2014-11-20
Estimated PCD
2022-11-14
Trial end
2022-11-14
Status
Completed
Treatment
Prise de sang
Arms:
Controls, Type-1 diabetes patients
Size
206
Primary endpoint
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
3 mois
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 206, 'type': 'ACTUAL'}}
Updated at
2023-09-11

1 organization

1 product

1 indication

Indication
Type 1 diabetes