Pharmacokinetics in Morbid Obesity After Bariatric Surgery

Overweight Clinical Trial

— FAROBE/1  

Official title:

Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086722
• Other study ID #: FAROBE/1
• Secondary ID: 2009-013156-72
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 3, 2010
• Last updated: October 14, 2015
• Start date: February 2010
• Est. completion date: March 2013

Study information

• Verified date: October 2015
• Source: Fundacion IMIM
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid
• Overweight

Intervention

Drug:
• "karolinska cocktail"
The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	IMIM-Hospital del Mar	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion IMIM	Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic ratios of probe substances	Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.	8 hours after drug administration	No
Secondary	Pharmacokinetics of probe substances	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	0-8 hours	Yes