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Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03563287
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Diabetes Research Foundation, Finland
Finnish Cultural Foundation
Kuopio University Hospital
Academy of Finland
Information provided by (Responsible Party):
Jussi Pihlajamäki, University of Eastern Finland

Study Description
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Brief Summary:

Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required.

The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs.

The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).

The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Bariatric Surgery Candidate Drug: cocktail of nine CYP probe drugs Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
Actual Study Start Date : January 27, 2012
Actual Primary Completion Date : December 10, 2014
Actual Study Completion Date : December 10, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Phenotyping cocktail of 9 CYP probe drugs before surgery Drug: cocktail of nine CYP probe drugs

Two equally loaded capsules containing:

Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules.
Experimental: Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery Drug: cocktail of nine CYP probe drugs

Two equally loaded capsules containing:

Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules.


Outcome Measures
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Primary Outcome Measures :
  1. Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB [ Time Frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour ]
  2. Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB [ Time Frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour ]

Secondary Outcome Measures :
  1. Metabolic ratios of parent compounds and corresponding metabolites before LRYGB [ Time Frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour ]
  2. Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB [ Time Frame: baseline, 1 hour, 2 hour, 4 hour and 6 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 40 kg/m2 or BMI 35-40 kg/m2 and a comorbidity or its risk factor, such as type 2 diabetes, hypertension, sleep apnea, osteoarthritis of weight bearing joints or polycystic ovarian syndrome;
  • previous conservative treatment for obesity had been proven to be ineffective;
  • patients were assigned to undergo LRYGB surgery
  • patients are able to give a written inform consent.

Exclusion Criteria:

  • smokers
  • consuming alcohol more than 20 g per day were included in the study
  • taking drugs which alter CYPs activity
  • history of hypersensitivity to the drugs used in the cocktail
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563287


Locations
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Finland
University of Eastern Finland
Kuopio, Finland
Sponsors and Collaborators
University of Eastern Finland
Diabetes Research Foundation, Finland
Finnish Cultural Foundation
Kuopio University Hospital
Academy of Finland
More Information
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Responsible Party: Jussi Pihlajamäki, Prof., University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03563287    
Other Study ID Numbers: NUDROBE
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight