Pretreatment of Patients Expecting Bariatric Surgery With the GLP-1 Analogon
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- weight reduction
研究概览
简要总结
The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue.
详细描述
The aim of this study is to investigate the effect of the treatment with the GLP-1 Analogon Liraglutide on the lipid metabolism an inflammation in adipose tissue. As GLP-1 is presumed to improve insulin sensitivity and associated parameters the investigators hypothesize that this might be due to changes in lipid metabolism which might be involved in the regulation of insulin sensitivity. Therefore the investigators intend to investigate changes of metabolic pathways before and after treatment with the GLP-1 analog liraglutide that could play a crucial role in pathogenesis as well as regulation of insulin sensitivity and atherogenic dyslipidemia such as: de novo lipogenesis and reverse cholesterol transport
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 35-55 Kg/m2
- •Fasting Blood glucose >140mg/dl
- •Planned bariatric surgery
- •Diabetic Medication (Metformin, Sulfonylurea, Insuline)
排除标准
- •Known hypersensitivity against Liraglutid
- •Pretreatment DPP-4 Inhibitors or GLP-1 Analogue the last 3 months
- •HbA1c >10%
研究组 & 干预措施
GLP-1 (Liraglutide)
Daily subcutaneous injection of Lirglutide over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg
干预措施: GLP-1 (Liraglutide) (Drug)
Placebo Comparator
Daily subcutaneous injection of PL1/PR1 Placebo over 9 weeks prior to bariatric surgery with a dosing of 0,6-1,8 mg
干预措施: Placebo (Drug)
结局指标
主要结局
weight reduction
时间窗: 4 years
to compare body weight with type 2 Diabetes scheduled for weight loss surgery after 8 weeks of preoperative treatment with either placebo or liragludite
次要结局
- GLP-1 Levels(4 years)