Long-term Follow-up of Diabetic Patients From the GLUTADIAB Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- The main objective of the study is to compare the plasma concentrations of glutamine in patients at the first visit (baseline) and the risk of cardiovascular events occurring until the GlutaDiab2 visit
研究概览
简要总结
Diabetes and related complications, particularly cardiovascular disease, are associated to exacerbated inflammation, which is characterized by an activation into a pro-inflammatory status of myeloid cells including blood monocytes and tissue macrophages.
It is known that monocytes and macrophages sense, integrate and respond to their microenvironment and continually monitor the availability of nutrients in order to adapt their activity and metabolism accordingly. However, the molecular mechanisms driving their activation and switch to a pro-inflammatory phenotype in diabetes are not fully elucidated.
The Tricarboxylic Acid cycle is a nexus for multiple nutrient inputs and the generation of Tricarboxylic Acid cycle metabolites is nowadays thought to orient macrophage polarization. Reduced glutamine concentrations have been reported in patients with type 2 diabetes compared to healthy individuals. Ex vivo studies (mainly performed in rodent models) have shown that glutamine catabolism (glutaminolysis) is involved in the activation of macrophages by generating Tricarboxylic Acid cycle intermediates that promote the pro-inflammatory polarization of macrophages. Yet, the link - glutamine catabolism, monocytes polarization and diabetes-related cardiovascular complications - remains unclear.
The first phase of this project (GlutaDiab) aimed to clarify this association by quantifying glutamine metabolism in serum and monocytes activation of type 1 and type 2 diabetic patients and investigating the possible correlation with the risk of cardiovascular complications in a transversal cohort.
The GlutaDiab2 is the second phase of this project and aims to further investigate the association between glutamine metabolism and cardiovascular risk by collecting follow-up data on cardiovascular events. This longitudinal data will also address the directionality of the association between glutamine metabolism, monocytes activation and cardiovascular risk.
详细描述
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 10 tubes (total: 53,5 mL) at a single time during the study
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
- 否
入选标准
- •Person previously enroled in the GLUTADIAB study in group 1 or 2 (cf appendix 1 for GLUTADIAB inclusion criteria)
排除标准
- •Pregnant or breastfeeding woman
- •Absence of free and informed consent
- •Subject deprived of freedom, subject under a legal protective measure
研究组 & 干预措施
Group 2
Patients with uncomplicated diabetes and high cardiovascular risk
干预措施: blood sampling (Biological)
Group 1
Patients with uncomplicated diabetes and low cardiovascular risk
干预措施: blood sampling (Biological)
结局指标
主要结局
The main objective of the study is to compare the plasma concentrations of glutamine in patients at the first visit (baseline) and the risk of cardiovascular events occurring until the GlutaDiab2 visit
时间窗: inclusion
The primary endpoint is the association between plasma concentration of glutamine in each subject and cardiovascular events occurring during follow-up.
次要结局
- To study cardiovascular events during follow-up according to glutamine metabolism in patients at baseline(inclusion)
- To study cardiovascular events during follow-up according to the inflammatory status in patients at baseline(inclusion)
- To study cardiovascular events during follow-up according to the monocyte activation status in patients at baseline(inclusion)
- To study glutamine metabolism variations between baseline and follow-up visit according to variation in cardiovascular risk(inclusion)