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Pharmacokinetics of Acetaminophen in Morbidly Obese Patients (APAP)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
acetaminophen 2 g
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morbid Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

normal weight patients

mobidly obese patients

Arm Description

normal weight patients receiving acetaminophen 2 g instead of 1 g

morbidly obese patients receiving acetaminophen 2 g instead of 1 g

Outcomes

Primary Outcome Measures

Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.
Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.

Secondary Outcome Measures

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.
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.
Liver function tests in morbidly obese patients in comparison with normal weight patients.

Full Information

First Posted
December 10, 2012
Last Updated
April 3, 2019
Sponsor
St. Antonius Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01764555
Brief Title
Pharmacokinetics of Acetaminophen in Morbidly Obese Patients
Acronym
APAP
Official Title
Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal weight patients
Arm Type
Experimental
Arm Description
normal weight patients receiving acetaminophen 2 g instead of 1 g
Arm Title
mobidly obese patients
Arm Type
Experimental
Arm Description
morbidly obese patients receiving acetaminophen 2 g instead of 1 g
Intervention Type
Drug
Intervention Name(s)
acetaminophen 2 g
Primary Outcome Measure Information:
Title
Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.
Time Frame
24 hours
Title
Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Liver function tests in morbidly obese patients in comparison with normal weight patients.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherijne Knibbe, Prof dr
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands

12. IPD Sharing Statement

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Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

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