Pharmacokinetics in Morbid Obesity After Bariatric Surgery

NCT ID: NCT01086722

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-03-31

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.

Conditions

Morbid Obesity; Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

"karolinska cocktail"

The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol

Group Type: EXPERIMENTAL

"karolinska cocktail"

Intervention Type: DRUG

The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

Interventions

"karolinska cocktail"

The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: collaborator

Fundacion IMIM

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Albert Goday, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Locations

Hospital del Mar

Barcelona, Barcelona, Spain

IMIM-Hospital del Mar

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 28560524 (View on PubMed)

Other Identifiers

2009-013156-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FAROBE/1

Identifier Type: -

Identifier Source: org_study_id