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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013156-72 | EudraCT Number |
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| Name | Class |
|---|---|
| Parc de Salut Mar | OTHER |
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Morbid obesity (MO) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. Drug bioavailability and metabolism in patients with MO is altered compared to population controls. Bariatric surgery is the gold standard treatment for MO when conventional therapy fails.
Bariatric surgery techniques can modify drug absorption in MO patients. These modifications depend on the drug absorption characteristics and on the bariatric surgery technique used. The changes in weight and body composition caused by BS at middle term can alter drug bioavailability and metabolism. The kinetics of the "normalization" process in patients with MO after bariatric surgery is unknown
Objectives. To analyze the changes in drug metabolism and pharmacokinetics. To establish drug dosing criteria in the post-intervention period in patients with MO after bariatric surgery. To determine the relationship between changes in drug bioavailability and metabolism in MO after bariatric surgery (longitudinal gastrectomy and Y-roux gastric by-pass).
Patients and methods. A prospective study of two cohorts of patients in a program of bariatric surgery (gastric by-pass and sleeve gastrectomy). Study "before and after".
Evaluations. Study on drug metabolism and pharmacokinetics using a modified "karolinska cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric surgery and at 4 weeks and 6 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "karolinska cocktail" | Experimental | The karolinska cocktail contains dextromethorphan, caffeine, losartan and omeprazol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "karolinska cocktail" | Drug | The "karolinska cocktail" contains dextrometorphan, caffeine, losartan and omeprazol |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolic ratios of probe substances | Metabolic ratios of parent drugs and metabolites in plasma and urine before and after bariatric surgery. | 8 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of probe substances | Comparison of the pharmacokinetics. Comparison of the metabolic ratios of probe substances between obese morbid patients and controls (normal weight and overweight). Adverse events observed after drug administration | 0-8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Goday, MD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain | ||
| IMIM-Hospital del Mar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28560524 | Derived | Goday Arno A, Farre M, Rodriguez-Morato J, Ramon JM, Perez-Mana C, Papaseit E, Civit E, Langohr K, Li Carbo M, Boix DB, Nino OC, Le Roux JAF, Pera M, Grande L, de la Torre R. Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques on Paracetamol and Caffeine Metabolism. Obes Surg. 2017 Dec;27(12):3194-3201. doi: 10.1007/s11695-017-2745-z. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Barcelona |
| Barcelona |
| 08003 |
| Spain |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |