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临床试验/NCT02381249
NCT02381249已完成不适用

The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery

St. James's Hospital, Ireland2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2015年3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
发起方
入组人数
40
试验地点
2
主要终点
Progressive ratio task breakpoint for a sweet-fat reward

研究概览

简要总结

Improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment.

Surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

Our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. These chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. Understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery.

In this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. The information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Esophagectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Octreotide (Drug)

Esophagectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Placebo (Drug)

Gastrectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Octreotide (Drug)

Gastrectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Placebo (Drug)

Unoperated healthy control

Active Comparator

Double-blind single dose octreotide-placebo crossover

干预措施: Octreotide (Drug)

Unoperated healthy control

Active Comparator

Double-blind single dose octreotide-placebo crossover

干预措施: Placebo (Drug)

Pancreaticoduodenectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Octreotide (Drug)

Pancreaticoduodenectomy

Experimental

Double-blind single dose octreotide-placebo crossover

干预措施: Placebo (Drug)

结局指标

主要结局

Progressive ratio task breakpoint for a sweet-fat reward

时间窗: 3 hours

次要结局

  • Number of rewards consumed(3 hours)
  • Subjective symptom score(3 hours)

研究者

发起方
St. James's Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jessie A Elliott

Surgical Research Fellow

St. James's Hospital, Ireland

研究点 (2)

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