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临床试验/NCT03384303
NCT03384303已完成不适用

Changes in Incretines, Gut Hormones and Bile Acids After Roux-en-Y Gastric

Rijnstate Hospital0 个研究点目标入组 10 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
主要终点
Change from baseline incretine levels during a standardized meal test four weeks after surgery.

研究概览

简要总结

Obesity is an increasing world wide problem. Moreover, the increase in patients who are considered morbidly obese is even higher (Sturm et al, Healt Aff 2004). Conservative approaches such as diets or medication are unsuccessful in the majority of the patients. Additionally, (morbid) obesity leads often to cardiovascular diseases, such as hypertension, dyslipidemia and type 2 diabetes (T2DM). When patients need insulin to regulate their glucose levels, their weight is even more difficult to control. Therefore, bariatric procedures are increasingly performed, with over 8.000 procedures in the Netherlands in 2013. The two most performed types of bariatric surgery in the Netherlands are the Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and the Laparoscopic Sleeve Gastrectomy (LSG). Within the LRYGB there are different variants available. In a recently initiated randomized controlled trial (RCT) from our centre, a comparison between two variants of RYGB was performed. In this RCT our standard RYGB (s-RYGB:alimentary limb (AL) of 150cm; biliopancreatic limb (BPL) of 75cm) was compared with a RYGB with an long BPL (LBPLRYGB:AL of 75cm and a BPL of 150cm). A LBPLRYGB might improve weight loss and reduction after surgery. The exact mechanism of action is still not fully understood. Stomach volume is decreased and satiety levels often increase, probably due to changes in incretin levels. Passage of foods through the gastrointestinal tract are altered after RYGB. A possible explanation might be found in different levels of incretins (such as GLP-1, PYY and ghrelin) and bile acids (FGF-19 and FGF-21) after bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

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

入选标准

  • General guidelines for bariatric surgery according to Fried (Fried et al, Obes Surg 2007).
  • Age > 18 years
  • Patients must be able to adhere to the study visit schedule and protocol requirements
  • Patients must be able to give informed consent and the consent must be obtained prior to any study procedures
  • Patients who are planned for a LRYGB

排除标准

  • Binge-eating or associated eating disorder
  • Active drug or alcohol addiction
  • Pregnancy and when giving breast feeding
  • A medical history of bariatric surgery
  • Patients with a language barrier which can inhibit patients to follow the correct medical advice
  • Any kind of genetic disorder that can inhibit patients to follow the correct medical advice

研究组 & 干预措施

S-RYGB

Other

干预措施: Standardized meal test (Other)

LBPL-RYGB

Other

干预措施: Standardized meal test (Other)

结局指标

主要结局

Change from baseline incretine levels during a standardized meal test four weeks after surgery.

时间窗: Preoperatively and four weeks after surgery

Change from baseline gut hormone levels during a standardized meal test four weeks after surgery.

时间窗: Preoperatively and four weeks after surgery

Change from baseline bile acid levels during a standardized meal test four weeks after surgery.

时间窗: Preoperatively and four weeks after surgery

次要结局

未报告次要终点

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frits Berends

Head of research department bariatric surgery

Rijnstate Hospital

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