Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

April 3, 2019 updated by: Catherijne Knibbe, St. Antonius Hospital

Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients

This study will investigate the pharmacokinetics of acetaminophen in morbidly obese patients versus normal weight patients. Specifically the different metabolic pathways of acetaminophen in morbidly obese adults will be investigated; glucuronidation, sulphation and CYP2E1 (cytochrome P450 2E1) oxidation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nieuwegein, Netherlands, 3435CM
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria for morbidly obese patients:

  • BMI > 40 kg/m2 undergoing bariatric surgery.
  • Patients between 18 - 60 years old
  • ASA physical classification of II or III
  • All racial and ethnic groups will be included

Inclusion criteria for control group:

  • BMI between 18 and 25 kg/m2 undergoing general surgery
  • Patients between 18 - 60 years old
  • ASA (American Society of Anesthesiology) physical classification of I, II or III
  • All racial and ethnic groups will be included

Exclusion criteria for all study arms:

  • Renal insufficiency
  • Liver disease
  • Patients with Gilbert-Meulengracht syndrome
  • Chronic alcohol intake or use of alcohol within last 72 hours
  • Pregnancy or breastfeeding
  • Patients who are treated with drugs know to affect CYP2E1 and UGT (UDP glucuronosyltransferase)
  • Diabetes mellitus type II patients
  • Smoking
  • Acetaminophen intake before the study (24 hours before study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: normal weight patients
normal weight patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g
Experimental: mobidly obese patients
morbidly obese patients receiving acetaminophen 2 g instead of 1 g
Drug: acetaminophen 2 g

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.
Time Frame: 24 hours
24 hours
Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.
Time Frame: 8 hours
8 hours
Difference in volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 - 2 year after bariatric surgery.
Time Frame: 8 hours
8 hours
Liver function tests in morbidly obese patients in comparison with normal weight patients.
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Antonius Hospital

Investigators

  • Principal Investigator: Catherijne Knibbe, Prof dr, St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APAP study
  • 2012-000956-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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