NCT02386917Active, not recruiting
Impact of Body Weight and Weight Loss on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers
Impact of Body Weight, Low Calorie Diet and Gastric Bypass on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers
Source: ClinicalTrials.gov · Last updated 2 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 24 Feb 2015
- Start date
- 18 Mar 2015
- Primary completion date
- Jun 2019
- Lead sponsor
- The Hospital of Vestfold
- Diseases
- Obesity
- NCT number
- NCT02386917
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 18 Mar 2015 to the primary completion date, Jun 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Previous bariatric or upper gastrointestinal surgery.
- Diabetic patients treated with glitazones, insulin or sulfonylureas.
Other illness
- Bradyarrhythmia, Wolff-Parkinson-White (WPW)-syndrome, atrioventricular block 2-3.
- Known hypersensitivity (including allergy) to drugs included in the cocktail and/or local anesthesia.
Lab values
- Renal impairment: eGFR \< 30 mL/min.
Other
- Electrolyte disturbances (particularly hypokalemia or hypomagnesemia).
- Blood donations the last 4 months.
- Pregnancy (checked with HCG in urine at screening) and breast-feeding mothers.
- Anticoagulants with associated risk in combination with biopsies.
- Non-compliance with regards to visits and/or diet.
Who the study is looking for
- Patients scheduled for GBP surgery or VLCD intervention for obesity as well as patients scheduled for cholecystectomy.
- BMI ≥ 18.5 kg/m2
- 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
- Stable body weight (\< 5 kg self reported weight change) during the last 3 months before inclusion.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HVestfold Coordinator of this site? Confirm its status | Tønsberg | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.