The Effect Of Satiety Gut Hormone Modulation On Appetitive Drive After Upper Gastrointestinal Surgery

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
First Submitted 2015-03-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-23
First Submitted that Met QC Criteria 2015-03-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-11-27
First Posted (ACTUAL) 2015-03-06	Results First Posted N/A	Last Verified 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/Arm	Intervention/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 Measures	Measure Description	Time Frame
Progressive ratio task breakpoint for a sweet-fat reward		3 hours

Secondary Outcome Measures	Measure Description	Time Frame
Number of rewards consumed		3 hours
Subjective symptom score		3 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

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

Investigators

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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