Exendin-9,39 and Satiety After Bariatric Surgery

Study Overview
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Brief Summary
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The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

Detailed Description
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Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider that the postprandial rise in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the increase in GLP-1 is less marked.

Official Title
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Exendin-9,39 and Satiety After Bariatric Surgery

Conditions
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Obesity

Intervention / Treatment
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* Drug: Saline
* Drug: Exendin-9,39


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years Healthy, with no active systemic illness Exclusion Criteria: Pregnancy Functional or organic bowel symptoms Systemic illness Diabetes Bariatric surgery > 2 years

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>0.9% NaCL (saline) intravenously for 6 hours. | Drug: Saline<br>* Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.<br>|
| Active Comparator: Exendin-9,39<br>Exendin-9,39 intravenously for 6 hours. | Drug: Exendin-9,39<br>* Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caloric Intake | caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Transit Measured Using Scintigraphy | Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve Gastrectomy, Roux-en-Y Gastric Bypass