Pharmacokinetics in Morbid Obesity After Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Morbid Obesity, Overweight

Intervention / Treatment
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* Drug: karolinska cocktail


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: karolinska cocktail<br>The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol | Drug: karolinska cocktail<br>* The karolinska cocktail contains dextrometorphan, caffeine, losartan and omeprazol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic ratios of probe substances | 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 | 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 |