Pharmacokinetics in Morbid Obesity After Bariatric Surgery

Phase 1

Completed

• Conditions: Morbid Obesity; Overweight
• Interventions: Drug: "karolinska cocktail"

• Registration Number: NCT01086722
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"karolinska cocktail"	"karolinska cocktail"	The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol

Primary Outcome Measures

Name	Time	Method
Metabolic ratios of probe substances	8 hours after drug administration	Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of probe substances	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

Trial Locations

Locations (2)

IMIM-Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain