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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-20

Study Completion Date

2022-11-14

Brief Summary

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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.

Detailed Description

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Conditions

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diabète de Type 1

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Type-1 diabetes patients

Group Type EXPERIMENTAL

Prise de sang

Intervention Type BIOLOGICAL

Controls

Group Type OTHER

Prise de sang

Intervention Type BIOLOGICAL

Interventions

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Prise de sang

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years
* 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

* 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)


* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Besançon

Besançon, , France

Site Status

CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 39330494 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35962339 (View on PubMed)

Other Identifiers

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BOUILLET AOI 2015

Identifier Type: -

Identifier Source: org_study_id

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