Back to resultsInfluence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients (ApoC1)
Primary Purpose
diabète de Type 1
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prise de sang
Sponsored by
About this trial
This is an interventional other trial for diabète de Type 1
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)
Sites / Locations
- CHU de Besançon
- CHU Dijon Bourgogne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Type-1 diabetes patients
Controls
Arm Description
Outcomes
Primary Outcome Measures
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
Secondary Outcome Measures
Full Information
NCT ID
NCT02816099
First Posted
June 24, 2016
Last Updated
September 8, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02816099
Brief Title
Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2014 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
diabète de Type 1
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type-1 diabetes patients
Arm Type
Experimental
Arm Title
Controls
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Prise de sang
Primary Outcome Measure Information:
Title
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
Time Frame
3 mois
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
CHU de Besançon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35962339
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.
Results Reference
derived
Learn more about this trial
Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients
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