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临床试验/EUCTR2017-000043-40-NL
EUCTR2017-000043-40-NL进行中(未招募)1 期

GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial - The GLOBE trial

Academic Medical Center0 个研究点目标入组 274 人开始时间: 2017年1月30日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
274

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, aged 18-80 years (inclusive),
  • No known diabetes mellitus, or
  • Known diabetes mellitus type 2 on oral glucose lowering medication, diet or total daily insulin dose =0.5 IU/kg
  • Scheduled for an elective cardiac surgical procedure.
  • Informed consent obtained before any trial-related activities are carried out.
  • 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 174
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Diabetes mellitus type 1
  • Emergency surgery
  • Receiving oral corticosteroid therapy
  • History of pancreatic surgery or acute or chronic pancreatitis
  • Personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia23 syndrome type 2 (MEN2)
  • Heart failure NYHA class IV
  • Serum-creatinine = 133 µmol l-1 for males and = 115 µmol l-1 for females, measured within 6 months before date of surgery.
  • Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • Current treatment with GLP-1 analogues
  • Known or suspected allergy to trial products or other drugs in the same class

研究者

发起方
Academic Medical Center

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