Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs
NCT Number: NCT06460896
Acronym: ABSORGYP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bypass Bariatric Surgery
Interventions: OTHER: pharmacokinetic study
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 64
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09
Completion Date: 2027-09
Locations: Service de chirurgie digestive, bariatrique et endocrinienne, Bobigny, 93000, France

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.

Primary Outcome Measures: 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, Difference in apparent clearance of study drugs between preoperative and postoperative phases at 1 month after surgery, preoperative and postoperative phases at 1 month after surgery
Secondary Outcome Measures: Determine changes in apparent clearance at 6 months after gastric bypass surgery compared with the pre-operative phase, Difference in apparent clearance of the 4 drugs studied between preoperative and postoperative phases at 6 months after gastric bypass surgery, pre-operative phase and 1 and 6 months after surgery|Explain changes in apparent clearance as a function of weight loss, Change in apparent clearance as a function of body weight loss, measured by bioelectrical impedancemetry, pre-operative phase and 1 and 6 months after surgery|Explain changes in apparent clearance as a function of changes in the fat/lean mass ratio, Change in apparent clearance as a function of change in body fat/lean mass ratio, measured by bioelectrical impedancemetry, pre-operative phase and 1 and 6 months after surgery|Determine changes in apparent volumes of distribution between the pre-operative phase and 1 and 6 months after surgery, Differences in apparent volume of distribution values between the pre-operative phase and 1 month, then 6 months after surgery, pre-operative phase and 1 and 6 months after surgery|Explain changes in apparent volumes of distribution as a function of body weight loss, Change in apparent volume of distribution as a function of body weight loss, pre-operative phase and 1 and 6 months after surgery|Explain changes in apparent volumes of distribution as changes in body fat, Change in apparent volume of distribution as change in body fat/lean body mass ratio, pre-operative phase and 1 and 6 months after surgery|Based on the results obtained, recommend any necessary changes in dosage or therapeutic class for these molecules, Dosages calculated to achieve the AUCs calculated before and 6 months after surgery, as well as the AUCs described for non-obese patients, at 1 month and 6 months post-surgery, pre-operative phase and 1 and 6 months after surgery