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临床试验/NCT04452786
NCT04452786撤回不适用

Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty

Hvidovre University Hospital2 个研究点 分布在 1 个国家开始时间: 2020年6月5日最近更新:
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适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Changes in ghrelin (pg/ml)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age > 18 years
  • •Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
  • •HbA1c < 48 mmol/mol before surgery, and no history of diabetes
  • •HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion

排除标准

  • •Hemoglobin < 6.5 mmol/l at inclusion
  • •Pregnancy or breast feeding
  • •Medication affecting the planned examinations

结局指标

主要结局

Changes in ghrelin (pg/ml)

时间窗: 240 minutes

Changes in ghrelin after a solid meal test compared before and after surgery

次要结局

  • Changes in gut hormone response before and after sugery (pmol/L)(240 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nora Elisabeth Hedbäck

Principal Investigator

Hvidovre University Hospital

研究点 (2)

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