ClinicalTrials.Veeva

Menu

Pharmacokinetics in Morbid Obesity After Bariatric Surgery (FAROBE/1)

F

Fundacion IMIM

Status and phase

Completed
Phase 2
Phase 1

Conditions

Overweight
Morbid Obesity

Treatments

Drug: "karolinska cocktail"

Study type

Interventional

Funder types

Other

Identifiers

NCT01086722
2009-013156-72 (EudraCT Number)
FAROBE/1

Details and patient eligibility

About

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).

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 1 patient group

"karolinska cocktail"
Experimental group
Description:
The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol
Treatment:
Drug: "karolinska cocktail"

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems