EUCTR2012-000216-28-AT进行中（未招募）1 期
Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression - SAPT-NODAT
Medizinische Universität Wien, Universitätsklinik für Innere Medizin III0 个研究点目标入组 50 人开始时间: 2012年12月5日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
- •Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose <126 mg/dL).
- •Receiving standard triple immunosuppressive medications that include tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids.
- •Capable of understanding the study and willing to give informed written consent for study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dL on two occasions at least three days apart.
- •Patients receiving an organ transplant other than kidney.
- •Patients receiving an unlicensed drug or therapy within one month prior to study entry.
- •Patients with history of hypersensitivity to injectable insulin.
- •Patients with documented HIV infection.
研究者
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