Elimination of acetaminophen in patients with extreme overweight

• Conditions: Morbid obesity; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-000956-32-NL
• Lead Sponsor: St. Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-24
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for morbidly obese patients:
- BMI > 40 kg/m2 undergoing bariatric surgery.
- 18 -60 years old
- ASA physical classification of II or III
- All racial and ethnic groups will be included

Inclusion criteria for normal weight patients:
- BMI between 18 and 25 kg/m2 undergoing general surgery
- 18 -60 years old
- ASA physical classification of I, II or III
- All racial and ethnic groups will be included

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria for all patient groups:
- Renal insufficiency identified by GFR < 60 ml/min/1.73m2
- Liver disease identified by liver function tests: ASAT, ALAT, prothrombin time, ?-GT, bilirubin, creatinine, albumin and alkaline phosphatase (ALP) ( > 3 times upper limit of normal values)
- Patients with Gilbert-Meulendracht 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-glucuronyltransferases)
- Diabetes mellitus type II patients
- Smoking
- Acetaminophen intake before the study (24 hours before study)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified