跳至主要内容
临床试验/NCT02010385
NCT02010385已完成不适用

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour - Impact of Gut Hormones

University College Dublin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Progressive ratio breakpoint

研究概览

简要总结

Among all the existing ways to treat obesity (lifestyle, pharmacological), Roux-en-Y gastric bypass (RYGB) surgery is currently the most effective. It results in long term weight loss maintenance, significant remission of obesity-related comorbidities and decreased overall mortality. It also induces changes in gastrointestinal hormones responses, with an increase of anorexigenic hormones GLP-1, and PYY.

Although successful, the mechanisms for RYGB-induced weight loss are not completely understood. The RYGB does result in increased satiation, decreased calorie intake and decreased preferences for sweet and fatty foods. Previous work from our lab has shown using progressive ratio task (PRT) that RYGB specifically decreases the appetitive behaviour for sweet and fat stimuli but not for vegetables. The reasons for this change in appetitive behaviour after the surgery remain unknown. They may be triggered by changes in gut hormones, conditioned taste aversion (negative post-ingestive effects) or changes in serum bile acids levels.

This study aims to assess whether RGYB-induced gut hormone changes contribute to the decrease in appetitive behaviour for sweet and fatty foods observed after the surgery.

This is a double blind controlled study comparing the effect of blocking gut hormones with somatostatin analogue (octreotide) on the appetitive behaviour for sweet-fat candies will be carried out. Appetitive behaviour will be measured using the progressive ratio task.

The investigators hypothesize that blocking the gut hormones in obese patients with RYGB will increase their appetitive behaviour for sweet-fat candies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

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

  • Gastric bypass surgery since at least 6 months

排除标准

  • serious illness
  • pregnancy or breast feeding
  • more than three alcoholic drinks per day
  • substance abuse
  • psychiatric illness
  • significant longstanding heart disease or heart intervention (for example, patients who have had heart attacks, have pacemakers or have had heart surgery)

研究组 & 干预措施

Octreotide

Active Comparator

One subcutaneous injection - 1 mL

干预措施: Octreotide (Drug)

Saline

Placebo Comparator

One subcutaneous injection - 1 mL

干预措施: Saline (Drug)

结局指标

主要结局

Progressive ratio breakpoint

时间窗: One hour

In the Progressive ratio task, the participants click a computer mouse in order to obtain a sweet/fat food reward. The effort required to obtain a reward is progressively increased. The breakpoint refers to the point at which the reward value of the food stimulus is lower than the effort necessary to obtain it and the participant stops pressing the button.

次要结局

  • Subjective ratings(One hour)
  • Gut hormones level(One hour)

研究者

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

Carel le Roux

Prof, PhD, MSc, MRCPath, MRCP, MBChB

University College Dublin

研究点 (1)

Loading locations...

相似试验