To investigate whether postprandial insulin release is affected by administration of the secundary BA DCA
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Insulin AUC
Secondary outcome
Glucose AUC
postprandial GLP-1 levels
postprandial FGF19 levels
Background summary
Traditionally, bile acids (BAs) have been thought to serve the purpose of
emulsifying nutrients. However, evidence has
emerged from animal and in-vitro studies that BAs also play a role in the
regulation of energy metabolism, particularly
glucose and fat metabolism. This is mediated through the BA receptors TGR5 and
FXR. Modulating BA kinetics in mice has been shown to affect insulin
sensitivity
Study objective
To investigate whether postprandial insulin release is affected by
administration of the secundary BA DCA
Study design
Healthy subjects will indergo a mixed meal test twice, once with and once
without oral administration of DCA. After the mixed meal, blood samples will be
taken at various timepoints.
Intervention
Addition of deoxycholate to the standard meal (1x)
Study burden and risks
Burden:
2x clinic visits of 5 hours each
2x placement of IV cannula for blood sampling, 225 ml in total
1 oral administration of DCA (10 mg/kg)
Because of the time spent and the invasive measurements, we estimate the burden
of this study to be moderate
Risks:
low risk of hematoma and/or phlebitis (IV cannula)
low risk of diarrhoea and/or abdominal cramping (infrequently described after
prolonged use of DCA)
low risk of reversible AST increase (infrequently described after prolonged use
of DCA; reversible upon dscontinuation)
We estimate the risks to be low and the possible consequences to be negligible
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
healthy males 18+
Exclusion criteria
Major illness in the past 3 months
Gastrointestinal disease that may influence bile acid metabolism
Abnormalities in ASAT / ALAT / Bilirubin / *GT / AF / fasting glucose / HbA1c laboratory data
Drug abuse or alcoholism (>3 units of alcohol per day)
History of cholecystectomy or other bile duct abnormalities.
Strenuous exercise for at least 3 days prior to each study day, defined as more than 1 hour of
exercise per day
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL44479.018.13 |
OMON | NL-OMON24716 |