Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Difference in Fasting Glucose
研究概览
简要总结
This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
- •Cardiac Surgery
- •Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin
排除标准
- •use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
- •glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
- •left ventricular assist device
- •percutaneous or laparoscopic surgery
- •end stage renal disease
- •end stage liver disease
- •history of pancreatitis
- •type 1 diabetes
- •pregnancy
- •unable to give consent in english
- •prisoners
- •less than 18 years of age
研究组 & 干预措施
Placebo
Patients will receive placebo prior to discharge and 6 weeks after discharge.
干预措施: Placebo (Drug)
Sitagliptin
Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Difference in Fasting Glucose
时间窗: 6 weeks
Difference in mean fasting glucose at 6 weeks post-discharge.
次要结局
未报告次要终点
研究者
Kathleen Dungan
Associate Professor
Ohio State University