Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Drug: Paracetamol
* Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI over 30 and eligible for sleeve gastrectomy Mentally capable for consent (for the antiepileptic drug intervention) chronic stable treatment of antiepileptic drug Exclusion Criteria: Gastrointestinal illness impairing absorption renal failure (glomerular filtration rate<45) liver cirrhosis heart failure (New York Heart Association class III or IV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants will undergo blood tests for pharmacokinetic of paracetamol before and 6 months after sleeve gastrectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paracetamol<br>10 participants will undergo measurement of paracetamol levels before and after sleeve gastrectomy | Drug: Paracetamol<br>* single dose of 1 gr paracetamol<br>|
| Experimental: antiepileptic drug<br>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 | Drug: Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)<br>* Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose<br>* Other names: Antiepileptic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic curve of paracetamol or antiepileptic drug: AUC | sequential measurement of paracetamol or antiepileptic drug (carbamazepine, lamotrigine, phenytoin or valproic acid), AUC | 8 hours |