Effects of obesity, non-alcoholic fatty liver disease and bariatric surgery on systemic cytochrome P450-mediated drug metabolism using a COCKTAIL approach.

Effects of obesity, non-alcoholic fatty liver disease and bariatric surgery on systemic cytochrome P450-mediated drug metabolism using a COCKTAIL approach. - COCKTAIL TRIAL

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50513

Enrollment

Registered

2018-08-13

Start date

2019-10-21

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesitas Obesity and non-alcoholic fatty liver disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
Primary study endpoints are the differences in area under the plasma concentration versus time curve (AUC) for each drug following the administration of the cocktail in four different situations/ disease states: (1) early (= anatomical) and (2) late and (3) very late (= weight reduction dependent) post-RYGB surgery compared to the pre-RYGB surgery situation.	—

Secondary

Measure	Time frame
Secondary endpoints include the differences in the PK parameters clearance, volume of distribution, absorption rate, mean residence time and elimination half-life in the above mentioned situations / disease states.	—

Countries

Netherlands

Outcome results