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
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