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

Gastrectomy, Eating Behaviour and GLP-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions Gastric Cancer
Dumping Syndrome
Interventions Other: Exendin 9-39
Other: Placebo
Enrollment 5
Recruitment Details Five participants recruited from Hereditary Diffuse Gastric Cancer patient population
Pre-assignment Details  
Arm/Group Title Placebo Then Exendin Exendin Then Placebo
Hide Arm/Group Description Infusion of 1% human albumin in normal saline on day one of study. Infusion of Exendin 9-39 in 1% human albumin in normal saline on day two of study (bolus of 7500pmol/kg followed by infusion of 500pmol/kg/minute for 4 hours).

Infusion of Exendin 9-39 in 1% human albumin in normal saline on day one of study (bolus of 7500pmol/kg followed by infusion of 500pmol/kg/minute for 4 hours).

Infusion of 1% human albumin in normal saline on day two of study.

Period Title: First Intervention - One Day
Started 3 2
Completed 3 2
Not Completed 0 0
Period Title: Second Intervention - One Day
Started 3 2
Completed 3 2
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description All participants were randomised to reveal both interventions, so baseline characteristics are reported for the whole study population.
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
1
  20.0%
Male
4
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 5 participants
5
1.Primary Outcome
Title Nadir Blood Glucose
Hide 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Crossover study - analysis by paired T test
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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.

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: mmol/l
3  (0.3) 4.4  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
2.Secondary Outcome
Title Total Insulin Secretion
Hide 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.
Time Frame Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: pmol*minute/l
41000  (10400) 14500  (2600)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
3.Secondary Outcome
Title Eating Rate During ad Libitum Meal
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: grams/minute
0.62  (0.12) 0.66  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments For meal consumption rate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
4.Secondary Outcome
Title Decreased Hunger and Satiety Ratings During and After ad Libitum Meal
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Unfortunately it proved impossible to collect data on hunger and fullness during the ad libitum meal, due to the cognitive effects of the gastrectomy which all of this group had undergone, meaning participants were unwilling to accurately record these sensations while eating. This data is therefore meaningless and was not analysed.
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Altered Food Attention.
Hide 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).
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).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: milliseconds
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Post-OGTT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Pre-meal
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Post-meal
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
6.Secondary Outcome
Title Altered Food Motivation
Hide 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).
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: Newton seconds
T0 / Baseline 508  (182) 219  (69)
Post-OGTT 139  (63) 274  (56)
Pre-meal 328  (82) 339  (116)
Post-meal 207  (82) 227  (116)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Post-OGTT
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments Paired analysis
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Pre-meal
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments Post-meal
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired analysis
7.Secondary Outcome
Title Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4
Hide Description [Not Specified]
Time Frame 24 hours from onset of infusion.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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.

Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Other
Comments 0 events over whole study, no statistical test appropriate
8.Secondary Outcome
Title Total Meal Consumption
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Exendin
Hide Arm/Group Description:

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).

Overall Number of Participants Analyzed 5 5
Mean (Standard Error)
Unit of Measure: grams
422  (45) 434  (162)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Exendin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 week.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Exendin
Hide Arm/Group Description

Infusion of 1% human albumin in normal saline.

Placebo: Infusion of 1% human albumin in normal saline

Infusion 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.

All-Cause Mortality
Placebo Exendin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Exendin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Exendin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mr Geoffrey Roberts
Organization: University of Cambridge
Phone: 01223767176
EMail: geoffroberts@cantab.net
Layout table for additonal information
Responsible Party: Geoffrey Roberts, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02971631     History of Changes
Other Study ID Numbers: A094265
218762 ( Other Identifier: IRAS )
First Submitted: November 17, 2016
First Posted: November 23, 2016
Results First Submitted: September 17, 2018
Results First Posted: August 29, 2019
Last Update Posted: August 29, 2019