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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
- •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.
- •Exclusion criteria:
- •Type 1 diabetes group:
- •- Initiation of lipid-lowering therapy during the 3 months of the study
研究组 & 干预措施
Patients with type 1 diabetes
Patients hospitalized in the Endocrinology, Diabetes, and Metabolic Diseases Department at the Dijon Bourgogne University Hospital due to poorly controlled diabetes.
干预措施: Blood test (Biological)
Patients with type 1 diabetes
Patients hospitalized in the Endocrinology, Diabetes, and Metabolic Diseases Department at the Dijon Bourgogne University Hospital due to poorly controlled diabetes.
干预措施: Urine sample (Biological)
Control
Patients who are neither diabetic nor hypoglycemic
干预措施: Blood test (Biological)
结局指标
主要结局
Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells
时间窗: Between Month 0 and Month 3
次要结局
未报告次要终点