The Effect of Satiety Gut Hormone Modulation on Appetitive Drive After Upper Gastrointestinal Surgery
NCT ID: NCT02381249
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-03-31
2018-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Esophagectomy
Double-blind single dose octreotide-placebo crossover
Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Gastrectomy
Double-blind single dose octreotide-placebo crossover
Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Unoperated healthy control
Double-blind single dose octreotide-placebo crossover
Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Pancreaticoduodenectomy
Double-blind single dose octreotide-placebo crossover
Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Interventions
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Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Disease-free at least one year post-resection
Exclusion Criteria
2. Significant and persistent chemoradiotherapy and/or surgical complication
3. Other previous upper gastrointestinal surgery
4. Unwell or unable to eat
5. Other disease or medications which may affect satiety gut hormone responses
6. Active and significant psychiatric illness including substance misuse
7. Cognitive or communication issues or any factors affecting capacity to consent to participation
8. History of significant food allergy, certain dietary restrictions
9. Confirmed or suspected residual or recurrent disease after surgery, second primary malignancy
10. Requiring adjuvant chemotherapy
11. Contraindication to octreotide administration
12. History of eating disorder
18 Years
100 Years
ALL
Yes
Sponsors
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University College Dublin
OTHER
University of Dublin, Trinity College
OTHER
Göteborg University
OTHER
St. James's Hospital, Ireland
OTHER
Responsible Party
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Dr Jessie A Elliott
Surgical Research Fellow
Principal Investigators
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John V Reynolds, MCh, FRCS
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, St. James's Hospital
Locations
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Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital
Dublin, , Ireland
Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg
Gothenburg, , Sweden
Countries
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References
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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.
HODOS W. Progressive ratio as a measure of reward strength. Science. 1961 Sep 29;134(3483):943-4. doi: 10.1126/science.134.3483.943.
Miholic 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.
Haverkort 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.
Koizumi 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.
le 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.
Elliott 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.
Related Links
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Wellcome Trust-HRB Clinical Research Facility
Conway Institute of Biomolecular and Biomedical Research
Other Identifiers
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CRFSJ 0057
Identifier Type: -
Identifier Source: org_study_id