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

October 14, 2015 updated by: Fundacion IMIM

Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08003
        • IMIM-Hospital del Mar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 hours after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion IMIM

Collaborators

Parc de Salut Mar

Investigators

  • Principal Investigator: Albert Goday, MD, Hospital del Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 3, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 14, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAROBE/1
  • 2009-013156-72 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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