Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 995
- 试验地点
- 2
- 主要终点
- Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk.
研究概览
简要总结
Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans
详细描述
The aim of the study is to investigate the role of glutamine metabolism in the pro-inflammatory activation of macrophages in diabetes and related cardiovascular complications.
The study focuses on 3 adult patients' population with different diabetic status and level of cardiovascular risk:
- Patients with uncomplicated type 1 or type 2 diabetes and low cardiovascular risk
- Patients with uncomplicated type 1 or type 2 diabetes and high cardiovascular risk
- Patients with complicated type 1 or type 2 diabetes
Participants (n=975) will be recruited at clinical sites, in the diabetes and cardiology departments (APHP, Bichat - Claude-Bernard Hospital and APHP, Lariboisière Hospital), over a 2-year period.
The study will consist in a single visit. During a scheduled hospitalization or consultation as part of the follow-up of their diabetes or as part of the follow-up of their cardiological problems, clinical data will be collected as well as additional blood and urine samples for analyses and biobanking. There will be no other intervention specific to the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Solid organ or bone marrow transplant patient
- •Pregnant or breastfeeding woman
- •Absence of free and informed consent
- •Non-affiliation to a social security regimen or CMU (universal health coverage)
- •Subject deprived of freedom, subject under a legal protective measure
研究组 & 干预措施
Group 1
Patients with uncomplicated diabetes and low cardiovascular risk
During a scheduled hospitalization or consultation as part of the follow-up of their diabetes additions of biological samples, which include:
A unique venous blood sampling of 9 tubes: 4 x 7 mL EDTA (Éthylènediaminetétraacétique) tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
干预措施: Bio collection (Biological)
Group 2
Patients with uncomplicated diabetes and high cardiovascular risk
During a scheduled hospitalization or consultation as part of the follow-up of their diabetes additions of biological samples, which include:
A unique venous blood sampling of 9 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
干预措施: Bio collection (Biological)
Group 3
Patients with complicated diabetes
During a scheduled hospitalization or consultation as part of the follow-up of their diabetes additions of biological samples, which include:
A unique venous blood sampling of 9 tubes: 4 x 7 mL EDTA tubes + 3 x 5 mL EDTA tubes + 2 x 4 mL no additive tubes (total: 51 mL) at a single time during the study and collection of 2 monovettes of 1.6 ml urine (total: 3.2 mL).
干预措施: Bio collection (Biological)
结局指标
主要结局
Compare the plasma concentrations of glutamine in patients with various levels of cardiovascular (CV) risk.
时间窗: DAY 1
plasma concentration of glutamine in each subject.
次要结局
- study the monocyte activation status in patients with various levels of CV risk(DAY 1)
- characterize the transcriptomic program through modification gene expression and epigenetic changes related to KDM6B (Lysine Demethylase 6B) and TET2 (Ten-eleven-translocation 2) activity in blood monocytes from patients with various levels of CV risk(DAY 1)
- study the inflammatory status in patients with various levels of CV risk(DAY 1)
- Study glutamine metabolism in patients with various levels of CV risk(DAY 1)
- characterize the transcriptomic program through modification gene expression and epigenetic changes related to KDM6B and TET2 activity in blood monocytes from patients with various levels of CV risk(DAY 1)