Clinical trial NCT02971631: Gastrectomy, Eating Behaviour and GLP-1
Official title: The Effect of Glucagon Like Peptide-1 (GLP-1) on Glycaemic Profile and Eating Behaviour Following Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Dumping Syndrome
Keywords: Dumping syndrome
Gastrectomy
GLP-1
Insulin
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-11-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Nadir Blood Glucose
timeFrame: As assessed during a 50g glucose tolerance test while receiving infusion of GLP-1 antagonist. At time 30-120 minutes of infusion of Exendin 9-39.
Secondary outcomes:
measure: Total Insulin Secretion
timeFrame: Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.
measure: Eating Rate During ad Libitum Meal
timeFrame: 150-210 minutes during infusion of Exendin 9-39 or placebo.
measure: Decreased Hunger and Satiety Ratings During and After ad Libitum Meal
timeFrame: 150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.
measure: Altered Food Attention.
timeFrame: 0-240 minutes during infusion of Exendin 9-39 or placebo, assessed on four occasions (baseline or T0, post-OGTT, pre-meal, post-meal) using a validated dot-probe visual response tool and reported in response time (milliseconds).
measure: Altered Food Motivation
timeFrame: 0-240 minutes during infusion of Exendin 9-39 or placebo (baseline or T0, post-OGTT, pre-m, assessed on four occasions using a validated grip strength surrogate of food motivation and measured as the area under the curve of a grip force monitoring curve.
measure: Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4
timeFrame: 24 hours from onset of infusion.
measure: Total Meal Consumption
timeFrame: 150-210 minutes during infusion of Exendin 9-39 or placebo
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: Geoffrey Roberts, MA BM BCh
role: PRINCIPAL_INVESTIGATOR
References: