DRUG
Acetaminophen
Acetaminophen dissolved in 50 ml of water
Status
Completed
Phase
Not applicable
Enrollment
10
Locations
1
Results
Not posted
Publications
1
Study 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.
Interventions
DRUG
Acetaminophen dissolved in 50 ml of water
DRUG
Metformin + acetaminophen dissolved in 50 ml of water
DRUG
Colesevelam + acetaminophen dissolved in 50 ml of water
OTHER
iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes
OTHER
iv. saline infusion 40 ml/hour for the first 60 minutes
Timeline
First posted
Aug 2, 2012
Study start
Jul 2012
Primary completion
Oct 2013
Study completion
Apr 2014
Results posted
Not reported
Registry updated
Jul 14, 2015
Outcomes
GLP-1 response as incremental area under curve (iAUC)
Time frame · -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240
Insulin
Time frame · -30, -15, 0, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 240
Eligibility
Inclusion Criteria: * HbA1c \< 6,0% * Not anaemic * Written informed consent Exclusion Criteria: * Liver disease * Nephropathy * fasting plasma glucose \> 5,6mM * Diabetes running in the family (parents or grandparents) * Any medical treatment * A former medical history of liver- or bile disease * any surgical procedure conducted in the abdomen * Body mass index \< 18,5 kg/m2 or \> 25 kg/m2
Study locations
Denmark. Showing up to 24 locations stored in the fast local snapshot.
University Hospital of Copenhagen, Gentofte Hospital, Diabetic Research Division
Copenhagen, Hellerup, Denmark
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Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.