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

Официальное название

Effect of Improved Glycemic Control on the Composition and Function of High-density Lipoproteins (HDL) in Patients With Type 1 Diabetes: a Prospective, Single-center Study. Comparison With Non-diabetic, Non-dyslipidemic Control Subjects. - HAGI-T1D Study

Обзор

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.

Вмешательства

• Биопрепарат Blood test
  Performed on an empty stomach at the initial visit and then at 3 months
• Биопрепарат Urine sample
  Performed only during the initial visit for patients with type 1 diabetes

Первичные конечные точки

• Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells [Срок оценки: Between Month 0 and Month 3]

Критерии участия

Критерии включения

Control group non-diabetic and non-dyslipidemic :

• 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).
• LDL cholesterol < 1,60 g/L.

Type 1 diabetes group :

• A person who has giver written consent
• Treated type 1 diabetes (regardless of the route of insulin administration).
• HbA1c > 8.0% (> 64 mmol/mol).

Критерии исключения

All participants :

• 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
• Adults who are legally incompetent or unable to give informed consent
• Minors
• Systemic inflammatory disease
• Medications that affect lipoprotein metabolism: immunosuppressive therapy, long-term corticosteroid therapy.

Control group non-diabetic and non-dyslipidemic :

• Diabetes or use of an antidiabetic medication.
• Dyslipidemia or use of lipid-lowering medication.
• Cardiovascular disease (history of stroke, myocardial infarction, coronary artery disease).
• Kidney disease (glomerular filtration rate CKD-EPI < 75 mL/min/1.73 m²)
• Presence of metabolic syndrome defined by the presence of at least three of the following criteria (NCEP-ATP III criteria):

• waist circumference > 102 cm in men, > 88 cm in women;
• fasting triglycerides > 1.70 mmol/L ( > 1.50 g/L);
• HDL cholesterol > 1.03 mmol/L in men and 1.29 mmol/L in women;
• systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg;
• fasting blood glucose ≥ 6.10 mmol/L (≥ 1.10 g/L).

Type 1 diabetes group:

• Diagnosis of type 1 diabetes within 12 months prior to enrollment.
• Glomerular filtration rate (CKD-EPI) < 60 mL/min/1.73 m².
• Albuminuria ≥ 30 mg/g creatinine.
• Initiation of lipid-lowering therapy within the month prior to the study.

Критерии исключения

Type 1 diabetes group:

\- Initiation of lipid-lowering therapy during the 3 months of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Chu Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07564752 · DENIMAL AOI 2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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