Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02386917

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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.

Treatments and study arms

Gastric bypass

Procedure

Weight loss surgery

Very low calorie diet

Behavioral

Non-surgical weight loss procedure

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

HVestfold🇳🇴 Tønsberg, Vestfold, Norway

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