Pharmacokinetics of Acetaminophen in Morbidly Obese Patients

NCT01764555 | Completed Phase 4 DMC

• 2 other identifiers: APAP study2012-000956-32
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

normal weight patients

EXPERIMENTAL

normal weight patients receiving acetaminophen 2 g instead of 1 g

Drug: acetaminophen 2 g

mobidly obese patients

EXPERIMENTAL

morbidly obese patients receiving acetaminophen 2 g instead of 1 g

Drug: acetaminophen 2 g

Interventions

acetaminophen 2 g DRUG

mobidly obese patients; normal weight patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St. Antonius Hospital

Nieuwegein, 3435CM, Netherlands

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Catherijne Knibbe, Prof dr

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: January 9, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

NL (1)