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Trial record 3 of 7 for:    "Postgastrectomy Syndrome" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Gastrectomy, Eating Behaviour and GLP-1

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ClinicalTrials.gov Identifier: NCT02971631
Recruitment Status : Completed
First Posted : November 23, 2016
Results First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Geoffrey Roberts, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Dumping Syndrome Other: Exendin 9-39 Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Glucagon Like Peptide-1 (GLP-1) on Glycaemic Profile and Eating Behaviour Following Gastrectomy
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : September 16, 2018
Actual Study Completion Date : September 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Infusion of 1% human albumin in normal saline.
Other: Placebo
Infusion of 1% human albumin in normal saline

Experimental: Exendin
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).




Primary Outcome Measures :
  1. 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. ]
    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 Outcome Measures :
  1. Total Insulin Secretion [ Time Frame: Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test. ]
    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.

  2. Eating Rate During ad Libitum Meal [ Time Frame: 150-210 minutes during infusion of Exendin 9-39 or placebo. ]
    As measured by universal eating monitor, total weight of a standardised meal consumed over a measured time in grams per minute.

  3. 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. ]
    Will be measured on visual analogue scale and reported as a score out of 100. Higher value indicated more hunger and more satiety.

  4. 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). ]
    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).

  5. 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. ]
    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).

  6. Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4 [ Time Frame: 24 hours from onset of infusion. ]
  7. Total Meal Consumption [ Time Frame: 150-210 minutes during infusion of Exendin 9-39 or placebo ]
    Total consumption amount of a standard meal during study intervention, measured in grams using a universal eating monitor.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971631


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Geoffrey Roberts, MA BM BCh University of Cambridge
  Study Documents (Full-Text)

Documents provided by Geoffrey Roberts, Cambridge University Hospitals NHS Foundation Trust:

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Responsible Party: Geoffrey Roberts, Clinical Research Associate, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02971631     History of Changes
Other Study ID Numbers: A094265
218762 ( Other Identifier: IRAS )
First Posted: November 23, 2016    Key Record Dates
Results First Posted: August 29, 2019
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geoffrey Roberts, Cambridge University Hospitals NHS Foundation Trust:
Dumping syndrome
Gastrectomy
GLP-1
Insulin
Additional relevant MeSH terms:
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Postgastrectomy Syndromes
Hormones, Hormone Substitutes, and Hormone Antagonists
Dumping Syndrome
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Postoperative Complications
Glucagon-Like Peptide 1
Incretins
Hormones
Physiological Effects of Drugs