NCT01900340

Intestinal Glucagon-like Peptide-1 (GLP-1) and the Physiological Role in Eating in Humans

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Appetite and General Nutritional Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Saline	Intravenous saline infusion and intraduodenal administration of saline via feeding tube
DRUG	Exendin 9-39	IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube
DIETARY_SUPPLEMENT	Saline	IV saline infusion and intraduodenal administration of nutrients
DRUG	Exendin(9-39) plus ID nutrient	Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2013-07-16
• Last updated: 2013-07-16

Locations

1 site across 1 country: Switzerland