Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460896
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-30
Brief Title:
Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABSORGYP
Brief 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
Detailed Description:
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 2021 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
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 2021 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None