Gastrectomy, Eating Behaviour and GLP-1

NHS Foundation Trust

Status: Completed

Conditions: Gastric Cancer; Dumping Syndrome

Treatments: Other: Placebo; Other: Exendin 9-39

Study type: Interventional

Funder types: Other

Identifiers

NCT02971631

218762 (Other Identifier)

A094265

Details and patient eligibility

About

Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer are known to have a significantly reduced quality of life. To date, there is very little information on the physiological causes of this. The investigators suspect that overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar symptoms seen in this group. To investigate this, the investigators will study the response of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will examine the levels of sugar and associated hormones in the blood, food consumption and food reward behaviour using standard tools.

Participants will be invited to attend the Clinical Research Facility at Addenbrooke's Hospital for a screening visit, and two whole day study visits. The study has been designed to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than assess the use of the blocking compound as a medication, and is therefore regarded as a physiological study, not a clinical trial.

The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and appetite derangement in patients who have had a gastrectomy. This will guide future work on the development of novel treatment paradigms for the post-gastrectomy patient group.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • At least 3 months post completion of treatment for gastric cancer, or prophylactic gastrectomy

  • Aged at least 18 years
  • Able to tolerate an oral glucose tolerance test
  • Able to understand and retain all information regarding the study and give informed consent.
  • Willing to receive an infusion of human albumin solution

Exclusion criteria

• • Have a diagnosis of diabetes

  • Have a history of untreated anaemia in the last 3 months
  • Be aged under 18 years
  • Have active gastric cancer
  • Be pregnant or attempting to conceive

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Infusion of 1% human albumin in normal saline.

Treatment:

Other: Placebo

Exendin

Experimental group

Description:

Infusion of Exendin 9-39 in 1% human albumin in normal saline

Treatment:

Other: Exendin 9-39