A Phase 1 interventional study of Saline and Exendin 9-39 in Appetite and General Nutritional Disorders, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-16.
Sponsored by University Hospital, Basel, Switzerland · Phase 1, Interventional, and Basic science
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.
275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's enrollment of 12 is below the median of 117 across 194 interventional studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
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Exclusion Criteria:
intravenous infusion of saline plus intraduodenal administration of saline
Dietary Supplement: Saline
intravenous infusion of exendin(9-39) plus intraduodenal administration of saline
Drug: Exendin 9-39
intravenous infusion of saline plus intraduodenal administration of nutrient
Dietary Supplement: Saline
Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
Drug: Exendin(9-39) plus ID nutrient
Intravenous saline infusion and intraduodenal administration of saline via feeding tube
IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube
IV saline infusion and intraduodenal administration of nutrients
Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
Effect of exendin(9-39)on total calorie intake
Time frame: 60 min test meal
Effect of exendin(9-39) on total fluid intake
Time frame: 60 min test meal
Effect of exendin(9-39)on meal duration during an ad libitum test meal.
Time frame: 60 min test meal
Effect of exendin(9-39)on plasma concentration of glucose
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of insulin.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of glucagon.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of GLP-1.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of peptide tyrosine tyrosine (PYY).
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of CCK.
Time frame: 4 hours blood sampling
Effect of exendin(9-39)on plasma concentration of ghrelin.
Time frame: 4 hours blood sampling
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland