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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381249
• Other study ID #: CRFSJ 0057
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: November 2023
• Source: St. James's Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Neoplasms
• Esophageal Neoplasms
• Malnutrition
• Neoplasms
• Pancreatic Neoplasms
• Stomach Neoplasms
• Weight Loss

Intervention

Drug:
• Octreotide
Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
• Placebo
Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen

Locations

Country	Name	City	State
Ireland	Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital	Dublin
Sweden	Gastrosurgical Laboratory, Sahlgrenska Academy, University of Gothenburg	Gothenburg

Sponsors (4)

Lead Sponsor	Collaborator
St. James's Hospital, Ireland	Göteborg University, University College Dublin, University of Dublin, Trinity College

Countries where clinical trial is conducted

Ireland,  Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sigstad score	Both categorical and continuous	3 hours
Primary	Progressive ratio task breakpoint for a sweet-fat reward		3 hours
Secondary	Number of rewards consumed		3 hours
Secondary	Subjective symptom score		3 hours

External Links

•   Conway Institute of Biomolecular and Biomedical Research
•   Department of Surgery, Trinity College Dublin and St. James's Hospital
•   Wellcome Trust-HRB Clinical Research Facility