NL-OMON50513RecruitingNot Applicable
Effects of obesity, non-alcoholic fatty liver disease and bariatric surgery on systemic cytochrome P450-mediated drug metabolism using a COCKTAIL approach. - COCKTAIL TRIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 17
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational invasive
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet the
- •following criteria:
- •- Capability to provide informed consent and to comply with the requirements
- •and restrictions listed on the informed consent form;
- •- Stable weight 3 months prior to inclusion;
- •- Obese, but otherwise healthy, with the exception of NAFLD, females, aged
- •between 18 - 45 years;
- •- Eligible and scheduled for laparoscopic RYGB surgery (in accordance with the
- •national guidelines (74)).
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Any medical disorder (with the exception of NAFLD and metabolic syndrome);
- •- Major illness in the past 3 months;
- •- History of cholecystectomy or other bile duct anomalies;
- •- (History of) (an) eating disorder(s);
- •- Use of prescription or non-prescription drugs and herbal or dietary
- •supplements that affect the CYP enzymes of interest within 30 days prior to the
- •administration of the drug cocktail, except for oral contraceptives;
- •- Diabetes;
- •- Drug abuse or alcoholism (>2 units of alcohol per day);
- •- Strenuous exercise for at least 3 days prior to each study day, defined as
- •more than 1 hour of exercise per day;
- •- Difficulty in donating blood or limited accessibility of a vein;
- •- Use of tobacco products (induction of liver enzymes).
Investigators
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