Very low calorie diet: Non-surgical weight loss procedure
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Bioavailability of drugs (1) — 0 hours and 0.25, 0.5, 1, 1.5, 2, 3, 4, 4.25, 4.5, 5, 5.5, 6, 8, 10*, 12*, 23 and 24 hours following administration Changes in absolute bioavailability (Area Under Curve - oral / Area Under Curve -intravenous) of midazolam after Gastric Bypass and Very Low Calorie Diet, respectively.
Bioavailability of drugs (2) — 0 hours and 0.25, 0.5, 1, 1.5, 2, 3, 4, 4.25, 4.5, 5, 5.5, 6, 8, 10*, 12*, 23 and 24 hours following administration Changes in bioavailability (Area Under Curve - oral) of caffeine, losartan, digoxin, rosuvastatin and omeprazole after Gastric Bypass and Very Low Calorie Diet, respectively.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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