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NCT Number: NCT03563287

Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs

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.

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland

Kuopio, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cocktail of nine CYP probe drugs

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Collaborators

  • Academy of Finland
  • Diabetes Research Foundation, Finland
  • Finnish Cultural Foundation
  • Kuopio University Hospital

Registry information

Official study title

Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 20, 2018
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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