跳至主要内容
临床试验/NCT03131232
NCT03131232Unknown不适用

The Aim of This Study is to Investigate the Protective Effect of Empagliflozin on the Cardiovascular System in Diabetes Mellitus Patients

RWTH Aachen University0 个研究点目标入组 46 人开始时间: 2015年12月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
46
主要终点
The effect of empagliflozine on glucose metabolism

研究概览

简要总结

In summary, the registry should provide novel insight into potential mechanisms of cardiovascular risk reduction in patients treated with Empagliflozin with an indication of intensified glucose lowering therapy based on their HbA1c level.

详细描述

Patients with diabetes exhibit an increased risk for the development of cardiovascular disease with a significantly impaired prognosis compared to patients without diabetes. Recent data from the EMPA-REG Outcome Trial suggest that treatment with the SGLT-2 inhibitor Empagliflozin reduces cardiovascular events, cardiovascular mortality as well as hospitalization for heart failure in patients with type 2 diabetes and pre-existing cardiovascular disease. Empagliflozin leads to reduction of blood glucose by an increased glucose excretion reduces blood pressure and weight. Still, it remains unclear how empagliflozin led to this pronounced reduction of cardiovascular mortality the EMPA-REG OUTCOME trial. Thus, our registry will analyse various biochemical as well as clinical markers in patients with type 2 diabetes and newly initiated treatment with empagliflozin. and an indication for intensification of glucose lowering therapy with empagliflozin. Patients with an indication for an intensified glucose-lowering therapy (HbA1c > 7,5%) will receive 10 mg empagliflozin and we will perform biochemical analyses of blood samples including insulin, glucagon as well as metabolites at baseline as well as after 1 and 6 months. In addition we will assess echocardiographical data.

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

入选标准

  • Diabetes mellitus II Patients with whom an empagliflozine treatment is to be initiated from a clinical indication

排除标准

  • Inability to consent to the study

结局指标

主要结局

The effect of empagliflozine on glucose metabolism

时间窗: 6 month

NT-pro BNP in pg/ml

次要结局

  • Lipid measurements(6 month)
  • Frequency of urinary and urogenital infections(6 month)
  • detection differential regulation of endogenous and exogenous metabolites in addition to circulating proteins by empagliflozin.(6 month)
  • - echocardiographic parameters (if collected) with determination of the systolic and diastolic left ventricular function(6 month)

研究者

申办方类型
Other
责任方
Sponsor

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