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临床试验/NCT02070081
NCT02070081已完成不适用

Patient Profiling for Successful Weight Loss After Gastric Bypass or Sleeve Surgery

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Weight loss

研究概览

简要总结

The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.

The specific aims are to evaluate:

a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark

排除标准

  • Inability to comply with the study protocol

研究组 & 干预措施

Surgery

Experimental

干预措施: Roux-en-Y gastric bypass surgery or sleeve surgery (Procedure)

结局指标

主要结局

Weight loss

时间窗: 3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively

次要结局

  • Social resources(3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively)
  • Bile acids and fibroblast growth factors(3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively)
  • Taste preferences and taste perception(3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively)
  • Genetics(3 month preoperatively)
  • Gut microbiota(1 week preoperatively, 6 month postoperatively)
  • Appetite-regulating hormones(3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively)
  • Physical activity(3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively)
  • Mental health(3 month preoperatively, 6 month postoperatively and 18 month postoperatively)
  • Body composition(3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively)
  • Metabolic profile(3 month preoperatively, 1 week preoperatively, 6 month postoperatively and 18 month postoperatively)
  • Appetite sensation(3 month preoperatively, 1 week preoperatively, 6 weeks postoperatively, 6 month postoperatively and 18 month postoperatively)
  • Cortisol(3 month preoperatively and 18 month postoperatively)
  • Rewarding value of food(preoperatively and 6 month postoperatively)
  • Neural activity in reward-processing brain centers(preoperatively and 6 month postoperatively)

研究者

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

Arne Astrup

Prof., MD, Head of Department of Nutrition, Exercise and Sports

University of Copenhagen

研究点 (2)

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