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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Parc de Salut Mar
Information provided by:
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01086722
First received: March 3, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Overweight
 Procedure: Surgery
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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:

U.S. FDA Resources

Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • Metabolic ratios of probe substances [ Time Frame: 8 hours after drug administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 72
Study Start Date: February 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Surgery
    Bariatric surgery (Gastric Bypass or Sleeve Gastrectomy)
    Other Name: Bariatric surgery
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086722

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

No publications provided

Responsible Party: Albert Goday, Hospital del Mar
ClinicalTrials.gov Identifier: NCT01086722     History of Changes
Other Study ID Numbers: FAROBE/1, 2009-013156-72
Study First Received: March 3, 2010
Last Updated: March 11, 2013
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013