Primary outcomeMean· 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.
Nadir Blood Glucose
| Group | Value (mmol/l) | Spread |
|---|---|---|
| Placebo | 3 | 0.3 |
| Exendin | 4.4 | 0.3 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataGastrectomy, Eating Behaviour and GLP-1
This trial does not test a peptide that PepBank tracks.
- Names Glucagon, does not test it. It appears in the title.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 5 participants (actual)
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United Kingdom
- Start
- 10 Aug 2017
- Primary completion
- 16 Sept 2018
- Completion
- 16 Sept 2018
- First posted
- 23 Nov 2016 (estimated)
- Last update posted
- 29 Aug 2019
- Conditions
- Gastric Cancer · Dumping Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Exendin 9-39Other
- PlaceboOther
Arms2
Placebo comparator
Placebo
Infusion of 1% human albumin in normal saline.
Experimental
Exendin
Infusion of Exendin 9-39 in 1% human albumin in normal saline
Primary outcomes1
Outcomes the sponsor listed as primary.
Nadir Blood Glucose
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.
Registry description
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.
Secondary outcomes(7)
Total Insulin Secretion
Time frame · Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.
Registry description
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.
Eating Rate During ad Libitum Meal
Time frame · 150-210 minutes during infusion of Exendin 9-39 or placebo.
Registry description
As measured by universal eating monitor, total weight of a standardised meal consumed over a measured time in grams per minute.
Decreased Hunger and Satiety Ratings During and After ad Libitum Meal
Time frame · 150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.
Registry description
Will be measured on visual analogue scale and reported as a score out of 100. Higher value indicated more hunger and more satiety.
Altered Food Attention.
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).
Registry description
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).
Altered Food Motivation
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.
Registry description
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).
Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4
Time frame · 24 hours from onset of infusion.
Total Meal Consumption
Time frame · 150-210 minutes during infusion of Exendin 9-39 or placebo
Registry description
Total consumption amount of a standard meal during study intervention, measured in grams using a universal eating monitor.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.
Total Insulin Secretion
| Group | Value (pmol*minute/l) | Spread |
|---|---|---|
| Placebo | 41000 | 10400 |
| Exendin | 14500 | 2600 |
Secondary outcomeMean· 150-210 minutes during infusion of Exendin 9-39 or placebo.
Eating Rate During ad Libitum Meal
| Group | Value (grams/minute) | Spread |
|---|---|---|
| Placebo | 0.62 | 0.12 |
| Exendin | 0.66 | 0.07 |
Secondary outcome· 150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.
Decreased Hunger and Satiety Ratings During and After ad Libitum Meal
| Group | Value |
|---|---|
| Placebo | not posted |
| Exendin | not posted |
Secondary outcomeMean· 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 Attention.
| Group | Value (milliseconds) | Spread |
|---|---|---|
| Placebo | 17.9 | 8.6 |
| Exendin | 11.1 | 7.1 |
Secondary outcomeMean· 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.
Altered Food Motivation
| Group | Value (Newton seconds) | Spread |
|---|---|---|
| Placebo | 508 | 182 |
| Exendin | 219 | 69 |
Secondary outcomeNumber· 24 hours from onset of infusion.
Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4
| Group | Value (participants) |
|---|---|
| Placebo | 0 |
| Exendin | 0 |
Secondary outcomeMean· 150-210 minutes during infusion of Exendin 9-39 or placebo
Total Meal Consumption
| Group | Value (grams) | Spread |
|---|---|---|
| Placebo | 422 | 45 |
| Exendin | 434 | 162 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboInfusion of 1% human albumin in normal saline. Placebo: Infusion of 1% human albumin in normal saline | 0 / 5 | 0 / 5 | 0 / 5 |
| ExendinInfusion of Exendin 9-39 in 1% human albumin in normal saline Exendin 9-39: Complete blockade of action of endogenous GLP-1 by Exendin 9-39. | 0 / 5 | 0 / 5 | 0 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 100 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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