Gastrectomy, Eating Behaviour and GLP-1

NCT ID: NCT02971631

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-10
• Study Completion Date: 2018-09-16

Brief Summary

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.

Conditions

Gastric Cancer; Dumping Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Infusion of 1% human albumin in normal saline.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Infusion of 1% human albumin in normal saline

Exendin

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

Group Type: EXPERIMENTAL

Exendin 9-39

Intervention Type: OTHER

Complete blockade of action of endogenous GLP-1 by Exendin 9-39. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Interventions

Exendin 9-39

Complete blockade of action of endogenous GLP-1 by Exendin 9-39. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Intervention Type: OTHER

Placebo

Infusion of 1% human albumin in normal saline

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Geoffrey Roberts

Clinical Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geoffrey Roberts, MA BM BCh

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

218762

Identifier Type: OTHER

Identifier Source: secondary_id

A094265

Identifier Type: -

Identifier Source: org_study_id