Skip to main content
OpenTrials
Completed

NCT Number: NCT01764555

Pharmacokinetics of Acetaminophen 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

acetaminophen 2 g

Drug

Primary outcomes

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

    Time frame: 24 hours

  2. Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.

    Time frame: 24 hours

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients

Acronym: APAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.