Pretreatment of patients expecting bariatric surgery with GLP-1 analog Liraglutide

niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 46 人开始时间: 2011年11月10日最近更新: 2021年4月26日

试验速览

暂无简介。

•1. Signed and dated informed consent obtained before any trial-related activities or procedures
•2. Male or female
•3. Aged 18 - 70 years
•4. BMI of 35 – 50 kg/m²
•5. Fasting blood glucose > 140 mg / dL
•6. Diabetes mellitus type 2
•7. Oral antidiabetic treatment
•8. Scheduled for bariatric surgery
•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 41
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•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. Serious thyroid dysfunction (ft4 > 2 times normal value)
•9. Heart insufficiency (NYHA 3 – 4)
•10. Renal failure (GFR < 50 L/min)
•11. Suspected or known drug or alcohol abuse
•12. Participation in another clinical trial
•13. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion

发起方

niversity Medical Center Hamburg-Eppendorf