Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Overview

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.

Full Title of Study: “Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2018

Detailed Description

Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol (in consenting subjects that are undergoing sleeve gastrectomy) and antiepileptic drugs (in consenting subjects that are chronically treated by a stable dose) before and 6 months after sleeve gastrectomy in 10 subjects. Blood tests will be taken for drug levels before and 4-8 times after the subject takes the drug. A pharmacokinetic curve will be calculated and compared for each subject between prior to surgery and after surgery.

Interventions

  • Drug: Paracetamol
    • single dose of 1 gr paracetamol
  • Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)
    • Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose

Arms, Groups and Cohorts

  • Experimental: paracetamol
    • 10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy
  • Experimental: antiepileptic drug
    • Up to 10 participants in each drug (up to 4 medications, total of up to 40 participants) will undergo measurement of levels of their chronic medication after a dose before and after sleeve gastrectomy

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC
    • Time Frame: 8 hours
    • sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC

Participating in This Clinical Trial

Inclusion Criteria

1. BMI over 30 and eligible for sleeve gastrectomy 2. Mentally capable for consent 3. (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug Exclusion Criteria:

1. Gastrointestinal illness impairing absorption 2. renal failure (glomerular filtration rate<45) 3. liver cirrhosis 4. heart failure (New York Heart Association class III or IV)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Irit HOCHBERG MD, Principle investigator, Attending physician in Institute of Endocrinology, Diabetes and Metabolism – Rambam Health Care Campus
  • Overall Official(s)
    • Irit Hochberg, MD/PhD, Principal Investigator, Rambam Healthcare Campus

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