Morbid obesity
Conditions
Interventions
Trade Name: acetaminophen
Product Name: acetaminophen
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acetaminophen
CAS Number: 130-90-2
Current Sponsor code: acetaminophen
Concentrati
Sponsors
St. Antonius Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
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: Exclusion criteria for all patient groups: - Renal insufficiency identified by GFR 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients.;Secondary Objective: - To compare the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients at the time of bariatric surgery and 0.5 – 2 year after bariatric surgery. - To compare the safety of acetaminophen in morbidly obese patients with normal weight patients. - Assess the influence of both demographic (age, sex) and physiologic covariates (body weight, insulin resistance, lipid levels and inflammation markers) on acetaminophen pharmacokinetics. - To evaluate the metabolomic profile in morbidly obese patients and normal weight patients. ;Primary end point(s): Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) and volume of distribution of acetaminophen in morbidly obese patients in comparison with normal weight patients.;Timepoint(s) of evaluation of this end point: Around bariatric surgery for the morbidly obese patients and around general surgery for the normal weight patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference in clearance (total, glucuronidation, sulphation, CYP2E1 oxidation) and volume of distribution of acetaminophen in morbidly obese patients at the time of bariatric surgery and at 0.5 – 2 year after bariatric surgery. - Liver function tests (ASAT, ALAT, prothrombin time, gamma- GT, bilirubin, creatinine and albumin) in morbidly obese patients in comparison with normal weight patients. Other endpoints that will be measured: - Total body weight, length and fat (free) mass - Insulin resistance: homa IR (fasting insulin and glucose levels) - Lipid levels: free fatty acids, triglycerides, cholesterol - Inflammation markers: TNF-alfa, IL-6, leptin, adiponectin and CRP - Metabolomic profile ;Timepoint(s) of evaluation of this end point: At the time of bariatric surgery and 0.5-2 years after bariatric surgery At the time of general surgery for the normal weight patients. | — |
Countries
Netherlands
Contacts
Public ContactAnne van Rongen, researcher
St. Antonius Hospital
Outcome results
None listed