Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein in Type-1 Diabetes Patients (ApoC1)

September 8, 2023 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besancon, France, 25030
        • CHU de Besancon
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Controls
Biological: Prise de sang
Experimental: Type-1 diabetes patients
Biological: Prise de sang

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparaison of linear correlation coefficients between plasma concentrations of apoC1 and CETP activity
Time Frame: 3 mois
3 mois

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2014

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimated)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOUILLET AOI 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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