The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
1 other identifier
interventional
40
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedNovember 27, 2023
November 1, 2023
3 years
March 2, 2015
November 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progressive ratio task breakpoint for a sweet-fat reward
3 hours
Secondary Outcomes (2)
Number of rewards consumed
3 hours
Subjective symptom score
3 hours
Other Outcomes (1)
Sigstad score
3 hours
Study Arms (4)
Esophagectomy
EXPERIMENTALDouble-blind single dose octreotide-placebo crossover
Gastrectomy
EXPERIMENTALDouble-blind single dose octreotide-placebo crossover
Unoperated healthy control
ACTIVE COMPARATORDouble-blind single dose octreotide-placebo crossover
Pancreaticoduodenectomy
EXPERIMENTALDouble-blind single dose octreotide-placebo crossover
Interventions
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy, breastfeeding
- Significant and persistent chemoradiotherapy and/or surgical complication
- Other previous upper gastrointestinal surgery
- Unwell or unable to eat
- Other disease or medications which may affect satiety gut hormone responses
- Active and significant psychiatric illness including substance misuse
- Cognitive or communication issues or any factors affecting capacity to consent to participation
- History of significant food allergy, certain dietary restrictions
- Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
- Requiring adjuvant chemotherapy
- Contraindication to octreotide administration
- History of eating disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. James's Hospital, Irelandlead
- University College Dublincollaborator
- University of Dublin, Trinity Collegecollaborator
- Göteborg Universitycollaborator
Study Sites (2)
Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, D8, Ireland
Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
Gothenburg, Sweden
Related Publications (7)
Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.
PMID: 22836034BACKGROUNDHODOS W. Progressive ratio as a measure of reward strength. Science. 1961 Sep 29;134(3483):943-4. doi: 10.1126/science.134.3483.943.
PMID: 13714876BACKGROUNDMiholic J, Orskov C, Holst JJ, Kotzerke J, Pichlmayr R. Postprandial release of glucagon-like peptide-1, pancreatic glucagon, and insulin after esophageal resection. Digestion. 1993;54(2):73-8. doi: 10.1159/000201016.
PMID: 8319842BACKGROUNDHaverkort EB, Binnekade JM, Busch OR, van Berge Henegouwen MI, de Haan RJ, Gouma DJ. Presence and persistence of nutrition-related symptoms during the first year following esophagectomy with gastric tube reconstruction in clinically disease-free patients. World J Surg. 2010 Dec;34(12):2844-52. doi: 10.1007/s00268-010-0786-8.
PMID: 20842361BACKGROUNDKoizumi M, Hosoya Y, Dezaki K, Yada T, Hosoda H, Kangawa K, Nagai H, Lefor AT, Sata N, Yasuda Y. Postoperative weight loss does not resolve after esophagectomy despite normal serum ghrelin levels. Ann Thorac Surg. 2011 Apr;91(4):1032-7. doi: 10.1016/j.athoracsur.2010.11.072.
PMID: 21440118BACKGROUNDle Roux CW, Aylwin SJ, Batterham RL, Borg CM, Coyle F, Prasad V, Shurey S, Ghatei MA, Patel AG, Bloom SR. Gut hormone profiles following bariatric surgery favor an anorectic state, facilitate weight loss, and improve metabolic parameters. Ann Surg. 2006 Jan;243(1):108-14. doi: 10.1097/01.sla.0000183349.16877.84.
PMID: 16371744BACKGROUNDElliott JA, Docherty NG, Haag J, Eckhardt HG, Ravi N, Reynolds JV, le Roux CW. Attenuation of satiety gut hormones increases appetitive behavior after curative esophagectomy for esophageal cancer. Am J Clin Nutr. 2019 Feb 1;109(2):335-344. doi: 10.1093/ajcn/nqy324.
PMID: 30722001DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John V Reynolds, MCh, FRCS
Department of Surgery, St. James's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgical Research Fellow
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 6, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
November 27, 2023
Record last verified: 2023-11