Clinical trial NCT01086722: Pharmacokinetics in Morbid Obesity After Bariatric Surgery
Official title: Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Morbid Obesity
Overweight
Lead sponsor: Fundacion IMIM
Sponsor class: OTHER
Collaborators: name: Parc de Salut Mar
First posted: 2010-03-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic ratios of probe substances
timeFrame: 8 hours after drug administration
Secondary outcomes:
measure: Pharmacokinetics of probe substances
timeFrame: 0-8 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: IMIM-Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Albert Goday, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goday Arno A, Farre M, Rodriguez-Morato J, Ramon JM, Perez-Mana C, Papaseit E, Civit E, Langohr K, Li Carbo M, Boix DB, Nino OC, Le Roux JAF, Pera M, Grande L, de la Torre R. Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques on Paracetamol and Caffeine Metabolism. Obes Surg. 2017 Dec;27(12):3194-3201. doi: 10.1007/s11695-017-2745-z.