Skip to main content
OpenTrials
Completed

NCT Number: NCT00331565

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital in Vestfold

Tønsberg, 3103, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for bariatric surgery.
  • 18 years of age or older.
  • Ongoing treatment with statin.
  • Able and willing to donate GI-tract and liver biopsies.
  • Signed informed consent.

Exclusion criteria

  • Concomitant treatment with drugs and/or other factors that may influence atorvastatin pharmacokinetics

Treatment and study plan

bariatric surgery

Procedure

Gastric bypass, duodenal switch and sleeve surgery

Primary outcomes

  1. ratio of atorvastatin AUC0-8 between groups

    Time frame: june 2009

Secondary outcomes

  1. Change in bioavailability of atorvastatin within each surgical technique will be analyzed as ratio of AUC0-8 from before to after surgery in accordance to the bioequivalence criteria of 80-125%.

    Time frame: june 2009

  2. Descriptive comparison of mRNA expression of CYP3A4, CYP3A5, P-gp and OATP1B1 in different biopsies and atorvastatin and metabolites pharmacokinetics.

    Time frame: june 2009

  3. Descriptive comparison of protein expression of CYP3A4, CYP3A5 and P-gp in different biopsies and atorvastatin and its metabolites pharmacokinetics.

    Time frame: december 2009

  4. Descriptive listing of atorvastatin and metabolites concentrations in patients with different genotypes analyzed. It is anticipated that an exploratory analysis will be performed to compare the groups.

    Time frame: june 2009

  5. Descriptive listing of the relationship between plasma and skeletal muscle as well as adipose tissue concentrations of atorvastatin and metabolites.

    Time frame: december 2009

  6. Adverse events and serious adverse events will be listed.

    Time frame: june 2009

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Collaborators

  • The Hospital of Vestfold

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
May 31, 2006
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.