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The aim is to further establish a physiological role for GLP-1 as an endogenous satiety signal by examining the effect of the specific GLP-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.
Understanding the exact mechanisms by which GLP-1 inhibits eating can be crucial in order to convert its anorectic action into useful, safe and effective drugs. So far, it is however not clear to what extent GLP-1 is a hormonal regulator of eating or whether the observed effects are rather a pharmacological phenomenon. By applying classical algorithms from endocrinology several criteria must be fulfilled before a hormone can be considered an endogenous physiological satiety signal. One is that exogenous administration of a selective antagonist should prevent the eating-inhibitory effect of GLP-1. At present, cholecystokinin (CCK) is the only peptide in humans identified to fit these criteria. For intestinal GLP-1, it has not been investigated whether a specific GLP-1 receptor antagonist can block the eating-inhibitory effect in humans. The availability of a specific GLP-1 receptor antagonist, exendin (9-39), now makes it possible to further investigate this pathway. Exendin (9-39), is a powerful tool available for human use to characterize of endogenous GLP-1 as a physiological regulator of different biological functions. The molecule has been used to document that endogenous GLP-1 is an important incretin hormone and a regulator of antro-pyloro-duodenal motility. The role of endogenous GLP-1 in regulating food intake and appetite has, however, not been investigated before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iv saline, intraduodenal saline | Placebo Comparator | intravenous infusion of saline plus intraduodenal administration of saline |
|
| IV exendin(9-39) plus intraduodenal (ID) saline | Active Comparator | intravenous infusion of exendin(9-39) plus intraduodenal administration of saline |
|
| IV saline, intraduodenal nutrient | Placebo Comparator | intravenous infusion of saline plus intraduodenal administration of nutrient |
|
| Exendin(9-39) plus ID nutrient | Active Comparator | Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Dietary Supplement | Intravenous saline infusion and intraduodenal administration of saline via feeding tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of exendin(9-39)on total calorie intake | 60 min test meal | |
| Effect of exendin(9-39) on total fluid intake | 60 min test meal | |
| Effect of exendin(9-39)on meal duration during an ad libitum test meal. | 60 min test meal |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of exendin(9-39)on plasma concentration of glucose | 4 hours blood sampling | |
| Effect of exendin(9-39)on plasma concentration of insulin. | 4 hours blood sampling | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Beglinger, MD | University Hospital Basel, Phase 1 Research Unit, Basel Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Phase 1 Research Unit | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24965303 | Derived | Steinert RE, Schirra J, Meyer-Gerspach AC, Kienle P, Fischer H, Schulte F, Goeke B, Beglinger C. Effect of glucagon-like peptide-1 receptor antagonism on appetite and food intake in healthy men. Am J Clin Nutr. 2014 Aug;100(2):514-23. doi: 10.3945/ajcn.114.083246. Epub 2014 Jun 25. |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C083773 | exendin (9-39) |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Exendin 9-39 | Drug | IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube |
|
| Saline | Dietary Supplement | IV saline infusion and intraduodenal administration of nutrients |
|
| Exendin(9-39) plus ID nutrient | Drug | Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration |
|
| Effect of exendin(9-39)on plasma concentration of glucagon. |
| 4 hours blood sampling |
| Effect of exendin(9-39)on plasma concentration of GLP-1. | 4 hours blood sampling |
| Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY). | 4 hours blood sampling |
| Effect of exendin(9-39)on plasma concentration of CCK. | 4 hours blood sampling |
| Effect of exendin(9-39)on plasma concentration of ghrelin. | 4 hours blood sampling |
| D017670 |
| Sodium Compounds |