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:
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
- 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
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