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, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label
Hospital in Vestfold
Active, not recruiting
University of Oslo School of Pharmacy
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00331565
- Information obtained from ClinicalTrials.gov on July 15, 2010
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Medical and Biotech [MESH] Definitions
Surgical procedures aimed at producing major WEIGHT REDUCTION in patients with MORBID OBESITY.
The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2.
Activities related to WEIGHT REDUCTION in patients with OBESITY. Treatment methods include DIET; EXERCISE; BEHAVIOR MODIFICATION; medications; and BARIATRIC SURGERY.
Surgical procedures involving the STOMACH and sometimes the lower ESOPHAGUS to correct anatomical defects, or to treat MORBID OBESITY by reducing the size of the stomach. There are several subtypes of bariatric gastroplasty, such as vertical banded gastroplasty, silicone ring vertical gastroplasty, and horizontal banded gastroplasty.
The discipline concerned with WEIGHT REDUCTION in patients with OBESITY.