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Clinical Trial Record

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

2015-03

2018-03

2018-03

40

Study Overview

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

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.

N/A

  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Weight Loss
  • Malnutrition
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • DRUG: Octreotide
  • DRUG: Placebo
  • CRFSJ 0057

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2015-03-02  

N/A  

2023-11-23  

2015-03-05  

N/A  

2023-11-27  

2015-03-06  

N/A  

2023-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
Quadruple

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Esophagectomy

Double-blind single dose octreotide-placebo crossover

DRUG: Octreotide

  • Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

DRUG: Placebo

  • Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
EXPERIMENTAL: Gastrectomy

Double-blind single dose octreotide-placebo crossover

DRUG: Octreotide

  • Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

DRUG: Placebo

  • Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
ACTIVE_COMPARATOR: Unoperated healthy control

Double-blind single dose octreotide-placebo crossover

DRUG: Octreotide

  • Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

DRUG: Placebo

  • Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
EXPERIMENTAL: Pancreaticoduodenectomy

Double-blind single dose octreotide-placebo crossover

DRUG: Octreotide

  • Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen

DRUG: Placebo

  • Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progressive ratio task breakpoint for a sweet-fat reward3 hours
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Number of rewards consumed3 hours
Subjective symptom score3 hours

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

    Inclusion criteria:
    1. 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 2. Disease-free at least one year post-resection
    Exclusion criteria:
    1. Pregnancy, breastfeeding 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • University College Dublin
  • University of Dublin, Trinity College
  • Göteborg University
  • PRINCIPAL_INVESTIGATOR: John V Reynolds, MCh, FRCS, Department of Surgery, St. James's Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
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