An interventional study of Exendin 9-39 and Placebo in Gastric Cancer and Dumping Syndrome, sponsored by Cambridge University Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Not applicable, Interventional, and Basic science
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.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 5 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least 3 months post completion of treatment for gastric cancer, or prophylactic gastrectomy
Exclusion Criteria:
Have a diagnosis of diabetes
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infusion of 1% human albumin in normal saline.
Other: Placebo
Infusion of Exendin 9-39 in 1% human albumin in normal saline
Other: 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).
Infusion of 1% human albumin in normal saline
Nadir Blood Glucose
Lowest blood sugar reading during an oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.
Time frame: 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.
Total Insulin Secretion
60 minute incremental area under the curve (i.e. total) insulin secretion during 50g oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.
Time frame: Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.
Eating Rate During ad Libitum Meal
As measured by universal eating monitor, total weight of a standardised meal consumed over a measured time in grams per minute.
Time frame: 150-210 minutes during infusion of Exendin 9-39 or placebo.
Decreased Hunger and Satiety Ratings During and After ad Libitum Meal
Will be measured on visual analogue scale and reported as a score out of 100. Higher value indicated more hunger and more satiety.
Time frame: 150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.
Altered Food Attention.
Food motivation can be measured by response rates to visual cues while being distracted by food related images. Will be measured with and without GLP-1 blockade to investigate effects of GLP-1 on food attention behaviour. Measure is of difference in response time when visual cue is colocated with a food related image vs a non-food related image, indicating degree of bias in attention to food images. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).
Time frame: 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).
Altered Food Motivation
Participant motivation to view particular food based cues is assessed by grip strength exerted to maintain those cues. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).
Time frame: 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.
Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4
Time frame: 24 hours from onset of infusion.
Total Meal Consumption
Total consumption amount of a standard meal during study intervention, measured in grams using a universal eating monitor.
Time frame: 150-210 minutes during infusion of Exendin 9-39 or placebo
Five participants recruited from Hereditary Diffuse Gastric Cancer patient population
| Milestone | Placebo Then Exendin | Exendin Then Placebo |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
| Milestone | Placebo Then Exendin | Exendin Then Placebo |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
Lowest blood sugar reading during an oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.
| mmol/l | Placebo | Exendin |
|---|---|---|
| Nadir Blood Glucose | 3 ± 0.3 | 4.4 ± 0.3 |
60 minute incremental area under the curve (i.e. total) insulin secretion during 50g oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.
| pmol*minute/l | Placebo | Exendin |
|---|---|---|
| Total Insulin Secretion | 41000 ± 10400 | 14500 ± 2600 |
As measured by universal eating monitor, total weight of a standardised meal consumed over a measured time in grams per minute.
| grams/minute | Placebo | Exendin |
|---|---|---|
| Eating Rate During ad Libitum Meal | 0.62 ± 0.12 | 0.66 ± 0.07 |
Will be measured on visual analogue scale and reported as a score out of 100. Higher value indicated more hunger and more satiety.
No measurements were reported for this outcome.
Food motivation can be measured by response rates to visual cues while being distracted by food related images. Will be measured with and without GLP-1 blockade to investigate effects of GLP-1 on food attention behaviour. Measure is of difference in response time when visual cue is colocated with a food related image vs a non-food related image, indicating degree of bias in attention to food images. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).
| milliseconds | Placebo | Exendin |
|---|---|---|
| Time 0 | 17.9 ± 8.6 | 11.1 ± 7.1 |
| Post OGTT | 18.2 ± 4.1 | 12.0 ± 9.0 |
| Pre-meal | 24.8 ± 10.8 | 17.9 ± 8.9 |
| Post-meal | 25.7 ± 10.8 | 10.7 ± 3.0 |
Participant motivation to view particular food based cues is assessed by grip strength exerted to maintain those cues. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).
| Newton seconds | Placebo | Exendin |
|---|---|---|
| T0 / Baseline | 508 ± 182 | 219 ± 69 |
| Post-OGTT | 139 ± 63 | 274 ± 56 |
| Pre-meal | 328 ± 82 | 339 ± 116 |
| Post-meal | 207 ± 82 | 227 ± 116 |
| participants | Placebo | Exendin |
|---|---|---|
| Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4 | 0 | 0 |
Total consumption amount of a standard meal during study intervention, measured in grams using a universal eating monitor.
| grams | Placebo | Exendin |
|---|---|---|
| Total Meal Consumption | 422 ± 45 | 434 ± 162 |
Collected over 1 week.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Exendin | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 1 |
| Male | 4 |
| Race and Ethnicity Not Collected(Participants) | All Participants |
|---|
| Region of Enrollment(participants) | All Participants |
|---|---|
| United Kingdom | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cambridge University Hospitals NHS Foundation Trust →