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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
NCT02386917 |
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Date of registration:
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24/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Body Weight and Weight Loss on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers
COCKTAIL |
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Scientific title:
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Impact of Body Weight, Low Calorie Diet and Gastric Bypass on Drug Bioavailability, Cardiovascular Risk Factors and Metabolic Biomarkers |
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Date of first enrolment:
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March 18, 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02386917 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Norway
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Contacts
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Name:
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Jøran Hjelmesæth, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital of Vestfold |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Procedure: Gastric bypass
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Behavioral: Very low calorie diet
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Primary Outcome(s)
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Bioavailability of drugs (2)
[Time Frame: 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]
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Bioavailability of drugs (1)
[Time Frame: 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]
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Secondary ID(s)
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2013-2379
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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