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| Name | Class |
|---|---|
| Diabetes Research Foundation, Finland | OTHER |
| Finnish Cultural Foundation | OTHER |
| Kuopio University Hospital | OTHER |
| Academy of Finland |
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Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required.
The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs.
The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).
The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenotyping cocktail of 9 CYP probe drugs before surgery | Experimental |
| |
| Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cocktail of nine CYP probe drugs | Drug | Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules. |
| Measure | Description | Time Frame |
|---|---|---|
| Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB | baseline, 1 hour, 2 hour, 4 hour and 6 hour | |
| Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB | baseline, 1 hour, 2 hour, 4 hour and 6 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic ratios of parent compounds and corresponding metabolites before LRYGB | baseline, 1 hour, 2 hour, 4 hour and 6 hour | |
| Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB | baseline, 1 hour, 2 hour, 4 hour and 6 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Eastern Finland | Kuopio | Finland |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| OTHER |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |