An interventional study of pharmacokinetic study in Bypass Bariatric Surgery, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other
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.
The aim of this study is to investigate the pharmacokinetics of some of the most frequently prescribed oral drugs in hospital and outpatient medicine, in patients undergoing GBP surgery for obesity associated with metabolic syndrome. Paradoxically, despite their frequency of use, very few data, contradictory data or no data at all characterize the molecules we wish to study.
The number of patients undergoing GBP surgery is growing rapidly, as their life expectancy reaches that of the general population once their weight has normalized. However, while weight loss induced by surgery can improve, and more rarely cure, the comorbidities associated with metabolic syndrome, the majority of patients will need to continue or modify their treatments.
It is therefore essential to know the pharmacokinetics of the antihypertensive, lipid-lowering and hypoglycemic drugs they will be taking throughout their lives, in order to adapt their dosage if necessary, or even to change therapeutic class if their absorption is insufficient after GBP.
Moreover, as some studies have shown, the pharmacokinetics of many molecules are likely to vary over time in these patients (19), probably as a result of weight loss itself, but also possibly due to adaptive phenomena in the digestive tract. Studying the pharmacokinetics of the molecules used in the usual treatment of metabolic syndrome in most obese patients should make it possible to: target the preferred sites of absorption in the digestive tract of the molecules studied, study the variations in absorption linked to GBP but also the pharmacokinetic changes linked to weight loss as a function of time. In fact, metabolic capacity may be both decreased and increased in obese patients compared to healthy subjects (20,21), so that drug clearance may both increase and decrease after weight normalization. It is therefore difficult to predict the pharmacokinetics of drugs immediately or long after GYP. The results obtained should make it possible to adapt treatment in these patients, both in terms of changing the dosage administered and in the choice of molecules.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
6 samples will be taken on the same day (T0, i.e. just before taking the drug, then T30 minutes, T1h, T2h, T4h, T7h after taking the drug).
Other: pharmacokinetic study
Multicenter pharmacokinetic study of the bioavailability of four compounds in GBP patients: candesartan, amlodipine, metformin and rosuvastatin.
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
Time frame: preoperative and postoperative phases at 1 month after surgery
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre-operative phase and 1 and 6 months after surgery
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris