Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients
NCT ID: NCT02816099
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
206 participants
INTERVENTIONAL
2014-11-20
2022-11-14
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
PARALLEL
OTHER
NONE
Study Groups
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Type-1 diabetes patients
Prise de sang
Controls
Prise de sang
Interventions
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Prise de sang
Eligibility Criteria
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Inclusion Criteria
* Patients with type-1 diabetes and glycated hemoglobin (HbA1C) \>9%
* 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
* Patients without national health insurance
* Pregnant or breast-feeding women
* Progressive cancer
* Treatment able to influence lipoprotein metabolism (oestroprogestatives, immunosuppressants, long-term corticotherapy)
* 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)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU de Besançon
Besançon, , France
CHU Dijon Bourgogne
Dijon, , France
Countries
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References
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Rouland A, Gautier T, Denimal D, Duvillard L, Simoneau I, Rageot D, Verges B, Bouillet B. The Endogenous Inhibitor of CETP, apoC1, Remains Ineffective In Vivo after Correction of Hyperglycemia in People with Type 1 Diabetes. Metabolites. 2024 Sep 7;14(9):487. doi: 10.3390/metabo14090487.
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.
Other Identifiers
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BOUILLET AOI 2015
Identifier Type: -
Identifier Source: org_study_id
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