The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Sur… (NCT02381249) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
Ireland, Sweden40 participantsStarted 2015-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Surgical procedure: Two-stage, three-stage or transhiatal esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with Roux-en-Y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects
. Disease-free at least one year post-resection
Exclusion criteria
. Pregnancy, breastfeeding
. Significant and persistent chemoradiotherapy and/or surgical complication
. Other previous upper gastrointestinal surgery
. Unwell or unable to eat
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied how gut hormone changes after upper GI surgery — like esophageal, stomach, or pancreatic surgery — affect appetite and food motivation, specifically using something called a 'progressive ratio task' to measure drive for sweet-fat foods; can you explain what that means for my own appetite and eating behavior after the type of surgery I'm facing?
2Since this trial is completed, have the results been published, and if so, what did they find about how satiety hormones change after upper GI surgery and whether that contributes to weight loss or malnutrition afterward?
3Weight loss and malnutrition are listed as specific conditions this trial focused on — how likely am I to experience significant weight loss or nutritional problems after my surgery, and is there a plan in place to monitor and manage that?
4The trial involved patients who had surgery on the esophagus, stomach, pancreas, or duodenum — given which surgery I need, would the gut hormone and appetite changes studied here be directly relevant to what I should expect in my recovery?
5Are there any current strategies or treatments — based on what research like this has found — that my care team would recommend to help protect my appetite and nutritional status after upper GI surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progressive ratio task breakpoint for a sweet-fat reward