Overweight Clinical Trial
Official title:
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).
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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