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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Parc de Salut Mar
Information provided by:
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT01086722
First received: March 3, 2010
Last updated: March 11, 2013
Last verified: March 2013

March 3, 2010
March 11, 2013
February 2010
March 2013   (final data collection date for primary outcome measure)
Metabolic ratios of probe substances [ Time Frame: 8 hours after drug administration ] [ Designated as safety issue: No ]
Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery.
Same as current
Complete list of historical versions of study NCT01086722 on ClinicalTrials.gov Archive Site
Pharmacokinetics of probe substances [ Time Frame: 0-8 hours ] [ Designated as safety issue: Yes ]

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

Pharmacokinetics of probe substances [ Time Frame: 0-8 hours ] [ Designated as safety issue: Yes ]

Comparison of the pharmacokinetics. Comparison of the metabolic ratios of probe substances between obese morbid patients and controls (normal weigth and overweigth).

Adverse events observed after drug administration

Not Provided
Not Provided
 
Pharmacokinetics in Morbid Obesity After Bariatric Surgery
Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques in Drugs Metabolism.

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).

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Morbid Obesity
  • Overweight
Procedure: Surgery
Bariatric surgery (Gastric Bypass or Sleeve Gastrectomy)
Other Name: Bariatric surgery
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
April 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01086722
FAROBE/1, 2009-013156-72
No
Albert Goday, Hospital del Mar
Fundacion IMIM
Parc de Salut Mar
Principal Investigator: Albert Goday, MD Hospital del Mar
Fundacion IMIM
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP