Pharmacokinetics in Morbid Obesity After Bariatric Surgery (FAROBE/1)
Recruitment status was Active, not recruiting
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 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.|
- 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.
- 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
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086722
|Hospital del Mar|
|Barcelona, Spain, 08003|
|IMIM-Hospital del Mar|
|Barcelona, Spain, 08003|
|Principal Investigator:||Albert Goday, MD||Hospital del Mar|