Morbid Obesity Clinical Trial
Official title:
Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin
Altered bioavailability of drugs will potentially affect both drug efficacy as well as
safety. In patients subjected to bariatric surgery due to morbid obesity the gastro
intestinal tract is considerably reconstructed and a change in drug bioavailability is very
likely. Getting further knowledge on important mechanisms responsible for altered
bioavailability would help in predicting clinically relevant consequences on different
drugs.
In the present study we aim to investigate the effect of bariatric surgery on atorvastatin
bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport
and will potentially be a good predictor for mechanisms relevant for other drugs as well.
In addition will the expression of different enzymes and transporters be measured in the
gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual
effects.
The primary objective of the study is to compare the effect of gastric bypass and BPD+DS
operations on atorvastatin bioavailability.
Secondary objectives are to determine the relative change in atorvastatin bioavailability
following gastric bypass as well as BPD+DS operations. In addition will the individual
CYP3A4, CYP3A5 and P-gp activity in the different organs from where biopsies can be obtained
be descriptively compared with atorvastatin pharmacokinetic variables.
;
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
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