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Impact of Body Weight and Weight Loss on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers

Active Not RecruitingNA

Sponsor: The Hospital of Vestfold

Conditions: Obesity

Interventions: Gastric bypass, Very low calorie diet

Countries: Norway

Drug bioavailability and disposition vary according to body weight and weight loss after bariatric surgery. This study evaluates the impact of body weight and weight loss on the pharmacokinetics of various probe drugs, and compares these effects in three groups of patients receiving either a gall bladder operation, gastric bypass or a very low calorie diet.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for GBP surgery or VLCD intervention for obesity as well as patients scheduled for cholecystectomy.
2. BMI ≥ 18.5 kg/m2
3. Able and willing to donate biopsies (as specified in the protocol) and for the GBP and VLCD patients also willing to perform follow-up 24 hour PK-investigations and other assessments as required by the clinical study protocol
4. Stable body weight (\< 5 kg self reported weight change) during the last 3 months before inclusion.
5. Signed informed consent.

Exclusion Criteria:

* Concomitant treatment with drugs (according to available literature, appendix 3) and/or other factors that may influence the cocktail drug pharmacokinetics such as grapefruit juice, Seville oranges, Pomelo juice, St. Johns wort, tobacco and coffee/tea in close approximation to the investigations.
* Bradyarrhythmia, Wolff-Parkinson-White (WPW)-syndrome, atrioventricular block 2-3.
* Electrolyte disturbances (particularly hypokalemia or hypomagnesemia).
* Renal impairment: eGFR \< 30 mL/min.
* Blood donations the last 4 months.
* Previous bariatric or upper gastrointestinal surgery.
* Diabetic patients treated with glitazones, insulin or sulfonylureas.
* Pregnancy (checked with HCG in urine at screening) and breast-feeding mothers.
* Known hypersensitivity (including allergy) to drugs included in the cocktail and/or local anesthesia.
* Anticoagulants with associated risk in combination with biopsies.
* Non-compliance with regards to visits and/or diet.

Locations (1)

Tønsberg, Vestfold, Norway