Morbid Obesity, Overweight
Conditions
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.
Interventions
DRUGkarolinska cocktail
The karolinska cocktail contains dextrometorphan, caffeine, losartan and omeprazol
Sponsors
Parc de Salut Mar
Fundacion IMIM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed