Bypass Bariatric SurgeryABSORGYPNCT06460896
Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs
A study testing pharmacokinetic study in people with Bypass Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bypass Bariatric Surgery
- What is being tested?
- pharmacokinetic study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Hypoglycemic agent: metformin
- Patients scheduled for Y-shaped gastric bypass surgery
- Membership of a social security scheme
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de chirurgie digestive, bariatrique et endocrinienne
Bobigny, 93000
Andrea LAZZATI
About this study
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.
Read the 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 (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.
- Conditions
- Bypass Bariatric Surgery
- Being tested
- pharmacokinetic study
- Keywords
- bypass bariatric surgery, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetic studyOther
Multicenter pharmacokinetic study of the bioavailability of four compounds in GBP patients: candesartan, amlodipine, metformin and rosuvastatin.
| Study group | Role | What they receive |
|---|---|---|
| Patients eligible for bypass bariatric surgery and treated for metabolic syndrome | Other | 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). Receives: Other: pharmacokinetic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: preoperative and postoperative phases at 1 month after surgery
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: pre-operative phase and 1 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bypass Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea LAZZATI, Principal investigator, Assistance Publique de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460896
- Sponsor's protocol ID
- APHP230873
- Acronym
- ABSORGYP
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Influence of Gastric By-Pass on the Pharmacokinetics of Common Drugs
- ClinicalTrials.gov ID
- NCT06460896
- Acronym / sponsor ID
- ABSORGYP / APHP230873
- Conditions
- Bypass Bariatric Surgery
- Keywords
- bypass bariatric surgery, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients eligible for bypass bariatric surgery and treated for metabolic syndrome | Other | Other: pharmacokinetic study6 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patients scheduled for Y-shaped gastric bypass surgery
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacokinetic studyMulticenter pharmacokinetic study of the bioavailability of four compounds in GBP patients: candesartan, amlodipine, metformin and rosuvastatin. | Other | Patients eligible for bypass bariatric surgery and treated for metabolic syndrome |
Primary outcome
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
Time frame: 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
7 secondary outcomes
Determine changes in apparent clearance at 6 months after gastric bypass surgery compared with the pre-operative phase
Time frame: pre-operative phase and 1 and 6 months after surgery
Explain changes in apparent clearance as a function of weight loss
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
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
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
Time frame: pre-operative phase and 1 and 6 months after surgery
Explain changes in apparent volumes of distribution as changes in body fat
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
Time frame: pre-operative phase and 1 and 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea LAZZATI principal investigator
Assistance Publique de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacokinetic study in people with Bypass Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea LAZZATI (06 67 47 66 03, andrea.lazzati@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: preoperative and postoperative phases at 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.