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The Effect of Improved Glycemic Control on the Composition and Function of High-Density Lipoproteins (HDL) in Patients With Type 1 Diabetes (HAGI-T1D)

2026年4月29日 更新者:Centre Hospitalier Universitaire Dijon

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

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.

研究概览

研究类型

观察性的

注册 (估计的)

143

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Patients with type 1 diabetes whose condition is poorly controlled

描述

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Exclusion criteria:

Type 1 diabetes group:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
Performed on an empty stomach at the initial visit and then at 3 months
Performed only during the initial visit for patients with type 1 diabetes
Control
Patients who are neither diabetic nor hypoglycemic
Performed on an empty stomach at the initial visit and then at 3 months

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Difference in the percentage of HDL-induced stimulation of eNOS activation via phosphorylation at serine 1177 in human HUVEC endothelial cells
大体时间:Between Month 0 and Month 3
Between Month 0 and Month 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月25日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年4月23日

首先提交符合 QC 标准的

2026年4月29日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月4日

上次提交的符合 QC 标准的更新

2026年4月29日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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