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临床试验/NCT01559779
NCT01559779已完成不适用

The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Change in beta cell function

研究概览

简要总结

The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Normal glucose tolerance
  • Age > 18 years
  • BMI > 40 or > 35 if combined with hypertension or obstructive sleep apnoea
  • Caucasian
  • Normal hemoglobinaemia
  • Signed informed consent

排除标准

  • Major psychiatric disorder
  • Alcohol or drug abuse
  • Major hearth or pulmonary disease
  • Previous major abdominal disease (e.g. peritonitis, large hernia)
  • Pregnancy/lactation
  • Treatment with GLP-1 analogs

结局指标

主要结局

Change in beta cell function

时间窗: Before and 1 week and 3 months after surgery

Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus

Insulinotropic effect of incretin hormones

时间窗: Before and 1 week and 3 months after surgery

Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline

次要结局

  • Change in alpha cell function(Before and 1 week and 3 months after surgery)

研究者

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

Carsten Dirksen

MD PhD student

Hvidovre University Hospital

研究点 (1)

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