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临床试验/NCT04055025
NCT04055025已完成不适用

Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Hvidovre University Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Ad libitum

研究概览

简要总结

Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.

详细描述

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

The study visits will be performed in randomized orders and participants will not now if they will receive ghrelin or saline.

入排标准

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

入选标准

  • The Danish national inclusion criteria for bariatric surgery
  • Signed written informed consent
  • Fasting plasma glucose <6.1 mmol/l

排除标准

  • Pregnancy or breastfeeding.
  • Hemoglobin <6.5 mM
  • Newly emerged serious disease

结局指标

主要结局

Ad libitum

时间窗: 240 minutes

Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery

次要结局

  • Ad libitum(240 minutes)
  • Ghrelin(240 minutes)

研究者

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

Nora Elisabeth Hedbäck

Medical Doctor

Hvidovre University Hospital

研究点 (2)

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