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Clinical Trials in France / NCT06460896
Starting soon Not applicable

Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs

NCT06460896 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-09
Last updated
2024-06-14

Condition(s) studied

Bypass Bariatric Surgery

Investigational drug(s) / intervention(s)

pharmacokinetic study

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)

Trial sites (1)

FacilityCityRegionStatus
Service de chirurgie digestive, bariatrique et endocrinienne Bobigny France

More Assistance Publique - Hôpitaux de Paris trials in France

Official registry record

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.

View NCT06460896 on ClinicalTrials.gov ↗ ← All trials in France