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临床试验/DRKS00004203
DRKS00004203招募中4 期

Pretreatment of patients expecting bariatric surgery with the GLP-1- Analogon Liraglutid

niversitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 46 人开始时间: 2015年5月28日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
46

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 70 Years(—)
性别
All

入选标准

  • 1. Signed and dated informed consent obtained before any trial-related activities or procedures
  • 2.BMI of 35 – 50 kg/m²
  • 3.Fasting blood glucose > 140 mg / dL
  • 4.Diabetes mellitus type 2
  • 5.Oral antidiabetic treatment with Metformin and/or Sulfonylurea before and during the trial
  • 6.Scheduled for bariatric surgery

排除标准

  • 1.Contraindication for liraglutide treatment as defined in the Summary of Product Characteristics (SmPC)
  • 2.Suspected or known hypersensitivity to liraglutide or any of its components
  • 3.Women of childbearing potential who are either breastfeeding, pregnant or not using a medically acceptable method of birth control
  • 4.Treatment with DPP IV inhibitors or GLP-1 analogues within the last three months
  • 5.Treatment with Insulin
  • 6.Pre-treatment with Liraglutide
  • 7.Type 1 diabetes mellitus
  • 8.HbA1c > 10 %
  • 9.Serious thyroid dysfunction (ft4 > 2 times normal value)
  • 10.Heart insufficiency (NYHA 3 – 4)
  • 11.Renal failure (GFR < 50 L/min)
  • 12.Suspected or known drug or alcohol abuse
  • 13.Participation in another clinical trial

研究者

发起方
niversitätsklinikum Hamburg-Eppendorf

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