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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000956-32 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal weight patients | Experimental | normal weight patients receiving acetaminophen 2 g instead of 1 g |
|
| mobidly obese patients | Experimental | morbidly obese patients receiving acetaminophen 2 g instead of 1 g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen 2 g | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria for morbidly obese patients:
Inclusion criteria for control group:
Exclusion criteria for all study arms:
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| Name | Affiliation | Role |
|---|---|---|
| Catherijne Knibbe, Prof dr | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital | Nieuwegein | 3435CM | Netherlands |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 8 hours |
| Liver function tests in morbidly obese patients in comparison with normal weight patients. | 24 hours |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |