Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01764555

Acronym

APAP

Enrollment

Registered

2013-01-09

Start date

2012-12-31

Completion date

2014-03-31

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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

Interventions

DRUGacetaminophen 2 g

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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.	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.	8 hours
Liver function tests in morbidly obese patients in comparison with normal weight patients.	24 hours

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026