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Pharmacokinetics in Morbid Obesity After Bariatric Surgery (FAROBE/1)

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: NCT01086722
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : October 16, 2015
Parc de Salut Mar
Information provided by (Responsible Party):
Fundacion IMIM

Brief Summary:

Morbid obesity (MO) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. Drug bioavailability and metabolism in patients with MO is altered compared to population controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy fails.

Bariatric surgery techniques can modify drug absorption in MO patients. These modifications depend on the drug absorption characteristics and on the bariatric surgery technique used. The changes in weight and body composition caused by BS at middle term can alter drug bioavailability and metabolism. The kinetics of the "normalization" process in patients with MO after bariatric surgery is unknown

Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug dosing criteria in the post-intervention period in patients with MO after bariatric surgery. To determine the relationship between changes in drug bioavailability and metabolism in MO after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).

Condition or disease Intervention/treatment Phase
Morbid Obesity Overweight Drug: "karolinska cocktail" Phase 1 Phase 2

Detailed Description:

Patients and methods. A prospective study of two cohorts of patients in a program of bariatric surgery (gastric by-pass and sleeve gastrectomy). Study "before and after".

Evaluations. Study on drug metabolism and pharmacokinetics using a modified "karolinska cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric surgery and at 4 weeks and 6 months post-intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.
Study Start Date : February 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: "karolinska cocktail"
The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol
Drug: "karolinska cocktail"
The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

Primary Outcome Measures :
  1. Metabolic ratios of probe substances [ Time Frame: 8 hours after drug administration ]
    Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.

Secondary Outcome Measures :
  1. Pharmacokinetics of probe substances [ Time Frame: 0-8 hours ]

    Comparison of the pharmacokinetics. Comparison of the metabolic ratios of probe substances between obese morbid patients and controls (normal weight and overweight).

    Adverse events observed after drug administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults (from 18 to 55 years)
  • Morbid Obesity BMI > 40 or BMI> 35 plus co-morbidity
  • Healthy controls (non-overweight and overweight groups)

Exclusion Criteria:

  • Allergy to study drugs
  • Liver diseases

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): NCT01086722

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Hospital del Mar
Barcelona, Spain, 08003
IMIM-Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Fundacion IMIM
Parc de Salut Mar
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Principal Investigator: Albert Goday, MD Hospital del Mar
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fundacion IMIM Identifier: NCT01086722    
Other Study ID Numbers: FAROBE/1
2009-013156-72 ( EudraCT Number )
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight