pharmacokinetic study: Multicenter pharmacokinetic study of the bioavailability of four compounds in GBP patients: candesartan, amlodipine, metformin and rosuvastatin.
Study summary
Lack of knowledge of digestive absorption of drugs used in metabolic syndrome (MS) before and after gastric by-pass (GBP) in obese patients. The main objective is to study the changes in apparent clearance of candesartan, amlodipine, metformin and rosuvastatin, used in the treatment of metabolic syndrome in obese patients, between the preoperative period and 1 and 6 months after the performance of a GBP.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥ 18 years
* Patients having undergone a complete bariatric course, eligible for bariatric surgery after validation of the operative indication by a multidisciplinary RCP dedicated to obesity, in accordance with HAS criteria: morbid obesity with BMI \> 40 kg/m2 or severe obesity with BMI \>35Kg/m2
* Patients with a comorbidity linked to one of the elements of metabolic syndrome that can be improved by surgery: type 2 diabetes, hypertension, dyslipidemia.
* Patients treated pre-operatively for at least 2 weeks with one or more of the molecules designed to control metabolic syndrome and selected for our study:
* Antihypertensive: amlodipine; candesartan,
* Hypolipidemic: rosuvastatin
* Hypoglycemic agent: metformin
* Patients scheduled for Y-shaped gastric bypass surgery
* Membership of a social security scheme
Exclusion Criteria:
* History of restrictive bariatric surgery (sleeve)
* History of renal or hepatocellular insufficiency
* Patient undergoing treatment or having stopped treatment within the last month with a drug that may alter the clearance of the molecules studied: enzyme inducer or inhibitor (boosted antiproteases, macrolides, azole antifungals, grapefruit juice, rifampicin, rifabutin, phenobarbital, phenytoin, St John's wort), probenecid, non-steroidal anti-inflammatory drugs, etc.
* Patients treated with a drug that may alter the bioavailability of associated drugs: antacids containing aluminium or magnesium hydroxide, gastric dressings, etc.
* Patients for whom it is impossible to give informed consent (language barrier)
* Patients taking part in another interventional clinical study
* Patients under legal protection (guardianship, curatorship)
* Pregnant or breast-feeding women
Primary outcome measure(s)
The main objective is to study the changes in apparent clearance of candesartan, amlodipine, metformin and rosuvastatin, used in the treatment of metabolic syndrome in obese patients — preoperative and postoperative phases at 1 month after surgery Difference in apparent clearance of study drugs between preoperative and postoperative phases at 1 month after surgery
Trial sites (1)
Facility
City
Region
Status
Service de chirurgie digestive, bariatrique et endocrinienne
Bobigny
France
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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