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

This study has been completed.
Parc de Salut Mar
Information provided by (Responsible Party):
Fundacion IMIM Identifier:
First received: March 3, 2010
Last updated: October 14, 2015
Last verified: October 2015

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 Intervention Phase
Morbid Obesity
Drug: "karolinska cocktail"
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.

Resource links provided by NLM:

Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 52
Study Start Date: February 2010
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "karolinska cocktail"
The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol
Drug: "karolinska cocktail"
The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

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.


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
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Please refer to this study by its identifier: NCT01086722

Hospital del Mar
Barcelona, Spain, 08003
IMIM-Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Fundacion IMIM
Parc de Salut Mar
Principal Investigator: Albert Goday, MD Hospital del Mar
  More Information

Responsible Party: Fundacion IMIM Identifier: NCT01086722     History of Changes
Other Study ID Numbers: FAROBE/1
2009-013156-72 ( EudraCT Number )
Study First Received: March 3, 2010
Last Updated: October 14, 2015

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 28, 2017