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

Primary Purpose

Morbid Obesity, Overweight

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
"karolinska cocktail"
Sponsored by
Fundacion IMIM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Hospital del Mar
  • IMIM-Hospital del Mar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

"karolinska cocktail"

Arm Description

The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol

Outcomes

Primary Outcome Measures

Metabolic ratios of probe substances
Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2010
Last Updated
October 14, 2015
Sponsor
Fundacion IMIM
Collaborators
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01086722
Brief Title
Pharmacokinetics in Morbid Obesity After Bariatric Surgery
Acronym
FAROBE/1
Official Title
Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion IMIM
Collaborators
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Overweight

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"karolinska cocktail"
Arm Type
Experimental
Arm Description
The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol
Intervention Type
Drug
Intervention Name(s)
"karolinska cocktail"
Intervention Description
The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol
Primary Outcome Measure Information:
Title
Metabolic ratios of probe substances
Description
Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.
Time Frame
8 hours after drug administration
Secondary Outcome Measure Information:
Title
Pharmacokinetics of probe substances
Description
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
Time Frame
0-8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Goday, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
IMIM-Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28560524
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.
Results Reference
derived

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Pharmacokinetics in Morbid Obesity After Bariatric Surgery

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