Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

Morbid Obesity Clinical Trial

— APAP  

Official title:

Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764555
• Other study ID #: APAP study
• Secondary ID: 2012-000956-32
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2019
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• acetaminophen 2 g

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of acetaminophen in morbidly obese patients in comparison with normal weight patients.		24 hours
Primary	Volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.		24 hours
Secondary	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
Secondary	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
Secondary	Liver function tests in morbidly obese patients in comparison with normal weight patients.		24 hours