The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon

About this trial

The HAGI-T1D study aims to determine the effect of improved glycemic control on the composition and function of high-density lipoproteins (HDL) in patients with type 1 diabetes (T1D). It requires the establishment of a biological plasma/serum bank.

T1D patients hospitalized in the Endocrinology-Diabetology-Metabolic Diseases Department at the Dijon Bourgogne University Hospital for poorly controlled diabetes (defined by glycated hemoglobin HbA1c \>8.0%).

The study includes a T1D group of 80 patients with unsatisfactory glycemic control, who will undergo intensified therapy in accordance with standard clinical practice (modification of insulin therapy, therapeutic education, and lifestyle and dietary guidelines). The study also includes a control group of 63 non-diabetic, non-dyslipidemic subjects enrolled based on the results of laboratory tests from the screening visit to assess whether improved glycemic control in the T1D group restores anti-atherogenic functions and HDL composition to a level comparable to that of the control group.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

A person who has giver written consent

Fasting blood glucose < 1,10 g/L

Triglycerides < 1,50 g/L (< 1,70 mmol/L).

HDL cholesterol > 1,03 mmol/L (men) or > 1,30 mmol/L (women).

Disqualifiers

A person who is not enrolled in or eligible for a social security program

A person subject to a legal protective measure (guardianship, tutorship)

A person subject to a judicial protective measure

Pregnant women, women in labor, or breastfeeding women

Trial population

Patients with type 1 diabetes whose condition is poorly controlled

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Biological/Vaccine

    Performed on an empty stomach at the initial visit and then at 3 months

  • Urine sample

    Biological/Vaccine

    Performed only during the initial visit for patients with type 1 diabetes

Treatment groups

143 Participants
are divided into 2 treatment groups
Group A: Patients with type 1 diabetes2 interventions
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells

Time frame
Between Month 0 and Month 3

Secondary outcomes

Other outcomes

Sponsors and contacts

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