NCT01656057

The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Filip Krag Knop · Academic / Other
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The last couple of years it has been shown that bile acids not only acts as simple emulsifiers of fat, but constitutes a complex metabolic integrator which not only have an influence on fat digestion and lipid metabolism, but also modulates the energy expenditure in (brown) adipose tissue and muscle tissue. This action is due to stimulation of the receptor TGR5 by bile acids. Recently scientists have discovered that this receptor in rodents is also expressed on the surface of intestinal L-cells (which normally secrets Glucagon-Like Peptide-1 (GLP-1) in response to nutrient stimulation). The stimulation of this receptor has shown a GLP-1 secretion from the intestinal cells which is interesting since GLP-1 has a central role in maintaining normal glucose tolerance and thus blood sugar. Given the above, bile acids has an important impact on intestinal GLP-1 secretion. Whether these scientific findings can be proven in human beings is uncertain. The primary hypothesis is that stimulating gall bladder emptying via Cholecystokinin (CCK) in healthy subjects will result in a significant GLP-1 response. We also hypothesize that adding orally Metformin or a sequestrant ("a bile acid binder") will further enhance this GLP-1 response.

Conditions

• To Assess the Impact of Bile Acids on Human Glukagon-like-peptide-1 Secretion

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen dissolved in 50 ml of water
DRUG	Metformin	Metformin + acetaminophen dissolved in 50 ml of water
DRUG	Colesevelam	Colesevelam + acetaminophen dissolved in 50 ml of water
OTHER	Cholecystokinin-8	iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes
OTHER	Saline	iv. saline infusion 40 ml/hour for the first 60 minutes

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2012-08-02
• Last updated: 2015-07-14

Locations

1 site across 1 country: Denmark