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

NCT02816099 | Completed

• 1 other identifier: BOUILLET AOI 2015
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

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.

Conditions

diabète de Type 1

Outcome Measures

Primary Outcomes (1)

• Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity

  3 mois

Study Arms (2)

Type-1 diabetes patients

EXPERIMENTAL

Biological: Prise de sang

Controls

OTHER

Biological: Prise de sang

Interventions

Prise de sang BIOLOGICAL

Controls; Type-1 diabetes patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CHU de Besançon

Besançon, 25030, France

Location

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (2)

• 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.

  PMID: 39330494 RESULT

• 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.

  PMID: 35962339 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 28, 2016
• Study Start: November 20, 2014
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (2)