Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- HgA1c
研究概览
简要总结
Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate in response to variations in doses of steroid and other immunosuppressive agents. At the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections. The investigators hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM would help patients with post-transplant diabetes attain better control at the critical time of titration of immunosuppressive regimens. The primary objective of this proposal is to improve glycemic control of diabetes with Pramlintide in patients with post-transplant diabetes at 3 and 6 months of therapy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-transplant diabetes (PTMD)
- •Aged 20-70
- •Diagnosis of diabetes within the last 6-18 months
- •Stable medications
- •Stable weight for 3 months
- •Serum creatinine < 1.5 mg/dL
排除标准
- •Pre-transplant diabetes
- •Major postoperative complications following transplant
- •Pregnancy
- •Significant GI discomfort with nausea or vomiting
- •Inability to learn continuous glucose monitoring
- •Development of diabetes more than 4 years after transplant
- •omen of child-bearing potential who use birth control pills and have fasting triglycerides of > 400 mg/dL
研究组 & 干预措施
Oral diabetic agents and pramlintide
干预措施: Pramlintide (Drug)
Insulin injection with pramlintide
干预措施: Pramlintide (Drug)
结局指标
主要结局
HgA1c
时间窗: 6 months
Primary outcomes utilized in this study will be endpoints of HbA1C
次要结局
- Continuous glucose monitoring(6 months)