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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00331565
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : December 3, 2014
The Hospital of Vestfold
Information provided by (Responsible Party):
University of Oslo School of Pharmacy

Brief 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Bariatric surgery Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin
Study Start Date : August 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Surgery
Bariatric surgery
Procedure: Bariatric surgery
Gastric bypass, duodenal switch and sleeve surgery

Primary Outcome Measures :
  1. ratio of atorvastatin AUC0-8 between groups [ Time Frame: june 2009 ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331565

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Hospital in Vestfold
Tønsberg, Norway, 3103
Sponsors and Collaborators
University of Oslo School of Pharmacy
The Hospital of Vestfold
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Principal Investigator: Rune Sandbu, MD, PhD Hospital in Vestfold
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Responsible Party: University of Oslo School of Pharmacy Identifier: NCT00331565    
Other Study ID Numbers: ATORVA-06
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by University of Oslo School of Pharmacy:
Bariatric surgery
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight