Effect of GLP-1 on Angiogenesis, Angiosafe Type 2 Diabetes Study 1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group
研究概览
简要总结
GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.
详细描述
GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. Beside their therapeutic benefits, direct cardiovascular effects have also been reported. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. T2D patients treated with GLP-1 analogs may suffer from microvascular complications such as macular oedema and proliferative retinopathy, characterized by excessive retinal angiogenesis. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The role of GLP-1 on endothelial cell (EC) growth, EC integrity and angiogenesis thus needs to be characterized. Our aim is to provide the proof of concept that agonists of GLP-1 regulate angiogenesis in humans and identify the underlying mechanisms. The present project is the translational part of the ANR Angiosafe-T2D, regarding clinical safety aspects of GLP-1 receptor agonists (namely Liraglutide) on angiogenesis.
The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 diabetic patients (ADA criteria)
- •Age > 18 years
- •Obesity (BMI >= 25 kg/m2)
- •HbA1c > 6.5 %
- •Treatment with Metformin and/or secretagogues
- •Effective contraception (women)
排除标准
- •Treatment with Exenatide, Liraglutide or other incretinergic regimen (<1 month before recruitment)
- •Type 1 diabetes
- •acute disease or infection
- •chronic renal failure (MDRD eGFR≤50 mL/min)
- •recent cardiovascular event or surgery (<3 months)
- •pancreatitis history
- •anti-VEGF treatment
- •untreated cancer
- •immunological disorders
- •pregnancy and lactation
- •Vulnerable people : deprivation of Liberty safeguards
- •hypersensitivity to the active substance or to any of the excipients of the investigational drug
- •diabetic ketoacidosis
- •heart failure stage 3 or 4 (NYHA III-IV)
- •Hepatic insufficiency
- •inflammatory bowel disease and gastroparesis
- •No affiliation to the social security
研究组 & 干预措施
1: Liraglutide
Liraglutide 1,2 mg once daily subcutaneous injection for 1 month (4 weeks)
干预措施: Liraglutide (Drug)
2: Add on oral antidiabetic medication
Metformin or sulfonylurea depending on monotherapy
干预措施: Metformin or sulfonylurea (Drug)
结局指标
主要结局
Difference of ANGPTL4 concentration at 4 weeks of treatment from baseline in Liraglutide and control group
时间窗: At 1 month
次要结局
- Difference of ANGPT2 concentration at 4 weeks of treatment from baseline in Liraglutide and control group(4 weeks)
- Difference of endothelial circulating progenitor cells (CD34+KDR+) concentration at 4 weeks of treatment from baseline in Liraglutide and control group(4 weeks)
- Difference of Circulating soluble adhesion molecules as endothelial activation markers: ICAM-1 and VCAM-1 concentration at 4 weeks of treatment from baseline (Liraglutide versus control group)(4 weeks)
- Difference of AngiomiR-126 expression at 4 weeks of treatment from baseline in Liraglutide and control group(4 weeks)