Clinical Trials Directory

Trials / Completed

CompletedNCT02445508

Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
University Hospital, Gentofte, Copenhagen · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Accumulating evidence suggests that bile acids in our intestines may constitute essential components in the complex mechanisms regulating gut hormone secretion and glucose homeostasis. Thus, it is likely that modification of the enterohepatic circulation of bile acids can lead to changes in gut hormone secretion and consequently affect glucose homeostasis. The current study is a human interventional randomized controlled cross-over study including four study days for each participant. As a tool to sequester bile acids we will use sevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adult patients with chronic kidney disease. Surprisingly, sevelamer has been shown to improve glycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenous infusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. The aim is to examine how (and if) bile acid sequestration can influence postprandial glucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2 diabetes. The investigators hypothesize that higher luminal concentrations of bile acids in the distal gut will elicit changes in gut hormone secretion. The current study will help to clarify this hypothesis and improve our general understanding of the association between bile acid circulation and signalling, gut hormone secretion and glucose metabolism.

Conditions

Interventions

TypeNameDescription
DRUGSevelamer
DRUGCholecystokinin
DRUGSevelamer placebo
DRUGIsotonic saline

Timeline

Start date
2015-05-01
Primary completion
2016-07-01
Completion
2016-07-01
First posted
2015-05-15
Last updated
2017-05-03

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT02445508. Inclusion in this directory is not an endorsement.