Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin

22:32 EST 28th November 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Morbid Obesity

Intervention

Bariatric surgery

Location

Hospital in Vestfold
Tønsberg
Norway
3103

Status

Active, not recruiting

Source

University of Oslo School of Pharmacy

Results (where available)

View Results

Links

Clinical Trials [513 Associated Clinical Trials listed on BioPortfolio]

Pharmacokinetics in Morbid Obesity After Bariatric Surgery

Morbid obesity (MO) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. Drug bioavai...

Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric byp...

Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future stud...

Endoscopic Surgery for Bariatric Revision After Weight Loss Failure

Morbid obesity and its associated metabolic diseases are on the rise in the United States. Currently, the best treatment for obesity is bariatric surgery where both roux-en-Y gastric bypas...

Longitudinal Assessment of Bariatric Surgery

The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

PubMed Articles [11970 Associated PubMed Articles listed on BioPortfolio]

Iodine Deficiency Is Higher in Morbid Obesity in Comparison with Late After Bariatric Surgery and Non-obese Women.

Iodine deficiency and obesity are worldwide-occurring health problems. Our purpose was to investigate the relationship between morbid obesity and iodine status, including subjects who lost weight afte...

Nutrition and Pregnancy after Bariatric Surgery.

Obesity is an escalating problem in all age groups and it is observed to be more common in females than males. About 25% of women meet the criteria of obesity and one-third of them are in the reproduc...

Can bariatric surgery improve cardiovascular risk factors in the metabolically healthy but morbidly obese patient?

Bariatric surgery has been shown to be effective in resolving co-morbid conditions even in patients with a body mass index (BMI)

The role of bariatric surgery in the treatment of diabetes.

The obesity epidemic contributes to approximately 44% of the world's type 2 diabetes burden. Bariatric surgery is an effective treatment for type 2 diabetes mellitus in patients with morbid obesity as...

Laparoscopic Sleeve Gastrectomy for Late Adolescent Population.

Morbid obesity prevalence is rapidly increasing among adolescents worldwide. Evidence is mounting that bariatric surgery is the only reliable method for substantial and sustainable weight loss; howeve...

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.

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