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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Blood test
Biological/VaccinePerformed on an empty stomach at the initial visit and then at 3 months
Urine sample
Biological/VaccinePerformed only during the initial visit for patients with type 1 diabetes
Treatment groups
Trial outcomes
Primary outcomes
Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells
Sponsors and contacts
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