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Completed

NCT Number: NCT02816099

Influence of Glycaemic Balance on the Ability of Apolipoprotein C1 to Inhibit Cholesteryl Ester Transfer Protein 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.

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Key information

Conditions

diabète de Type 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Prise de sang

Biological

Primary outcomes

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

    Time frame: 3 mois

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: ApoC1

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2016
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.