Perioperative Sitagliptin Medication for Reduction of the Inflammatory Response Associated With Cardiopulmonary Bypass and Postoperative Glucose Control in Diabetic Patients Undergoing Elective Cardiac Surgery - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total crystalloid volume-requirement within 24 hours after surgery
研究概览
简要总结
Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. Within this study the investigators examine the effects of perioperative Sitagliptin intake on the inflammatory response after cardiopulmonary bypass.
详细描述
Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. For example, it is known that DPP-4-inhibition prevents procalcitonin from being cleaved to a truncated form that lacks 2 amino acids. As the investigators described recently, truncated procalcitonin targets the CRLR-RAMP1-receptor on vascular endothelium and induces VE-cadherin-phosphorylation which leads to leakage of fluids and proteins from vessels. Furthermore, many other immunoregulatory targets such as substance p, CXCL10 or NF-kB have been reported to be modified by DPP-4. Therefore, it can be assumed that Sitagliptin possibly represents a powerful drug in inflammatory circumstances.
The aim of this study is to prove possible antiinflammatory properties by conducting an observational trial in cardiac surgery patients. All patients undergo cardiac surgery with the use of cardiopulmonary bypass (CBP) which is known to trigger a systemic inflammatory response syndrome (SIRS). Group 1 suffers from diabetes mellitus type two and regularly takes Sitagliptin which is continued perioperatively. Group 2 also suffers from diabetes mellitus type 2 but does not take Sitagliptin. Group 3 has no diabetes mellitus but also undergoes cardiac surgery. To determine the effect of Sitagliptin under inflammatory conditions deep immune phenotyping and a cytokine assay is performed from blood withdrawals 24h after surgery. Moreover, the sublingual microcirculation is measured two times after the operation.
Taking all measurements of the cellular immune system, the humoral immune system and the vasculature into account it should be possible to define the immunoregulatory effects of Sitagliptin treatment more properly.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age >18 years
- •Patients undergoing cardiac surgery with use of CBP and...
- •Diabetes mellitus type 2 with Sitagliptin treatment or,
- •Diabetes mellitus type 2 without Sitagliptin treatmet or,
- •No diabetes mellitus
- •Written informed consent
排除标准
- •Diabetes mellitus type 1
- •Treatment with another DPP4-inhibitor
- •Treatment with GLP-1-analoga
- •Emergency surgery
- •Chronic or acute infection
- •Pregnancy
- •Participation in an interventional study trial within last 3 months
- •Relationship to study investigators
研究组 & 干预措施
DM and Sitagliptin treatment
Cardiac surgery patients who suffer from diabetes mellitus type 2 and take Sitagliptin.
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Total crystalloid volume-requirement within 24 hours after surgery
时间窗: Retrospective data collection 24 hours after surgery
Retrospective data collection from the hospital information system
Total norepinephrine-requirement within 24 hours after surgery
时间窗: Retrospective data collection 24 hours after surgery
Retrospective data collection from the hospital information system
次要结局
- Immune cells surface markers(Measured 24 hours after surgery)
- Cytokine-levels(Measured 24 hours after surgery)
- Sublingual microcirculatory parameters: Total vessel density, Proportion of Perfused Vessels, Perfused Vessel Density, Microvascular Flow Index(Measured immediately after surgery and 24 hours after surgery)
研究者
Sebastian Kintrup
Principal Investigator
University Hospital Muenster