N/A
N=5
Gastrectomy, Eating Behaviour and GLP-1
Gastric Cancer · Dumping Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02971631 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Nadir Blood Glucose — 3; 4.4 mmol/l — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exendin 9-39 (Other); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nadir Blood Glucose |
3; 4.4 | 0.008 sig |
| SECONDARY Total Insulin Secretion |
41000; 14500 | 0.03 sig |
| SECONDARY Eating Rate During ad Libitum Meal |
0.62; 0.66 | 0.79 |
| SECONDARY Decreased Hunger and Satiety Ratings During and After ad Libitum Meal |
— | — |
| SECONDARY Altered Food Attention. |
17.9; 11.1; 18.2; 12.0; 24.8; 17.9 | 0.20 |
| SECONDARY Altered Food Motivation |
508; 219; 139; 274; 328; 339 | 0.26 |
| SECONDARY Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4 |
0; 0 | 1 |
| SECONDARY Total Meal Consumption |
422; 434 | 0.84 |
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
Data sourced from ClinicalTrials.gov (NCT02971631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.