Effects of laparoscopic sleeve gastrectomy on simvastatin absorption
The Need of Dosing Adjustment for Simvastatin in Obese Patients Post Bariatric Surgery- Laparoscopic Sleeve Gastrectomy (LSG)
PHASE4 · National University Hospital, Singapore · NCT03571802
This study is testing how laparoscopic sleeve gastrectomy affects the way the body absorbs simvastatin, a cholesterol-lowering medication, in people who are having this surgery and already take statins.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National University Hospital, Singapore (other) |
| Drugs / interventions | tocilizumab, imatinib |
| Locations | 1 site (Singapore) |
| Trial ID | NCT03571802 on ClinicalTrials.gov |
What this trial studies
This study investigates how laparoscopic sleeve gastrectomy (LSG) affects the pharmacokinetics of simvastatin, a commonly used medication for lowering cholesterol. It aims to understand changes in the drug's systemic exposure following the surgical procedure, as LSG alters gastrointestinal physiology, potentially impacting drug absorption. The study will include participants who are scheduled for LSG and are currently taking statins, focusing on the changes in bioavailability of simvastatin post-surgery. This research addresses a gap in the literature regarding the pharmacokinetics of simvastatin in the context of bariatric surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and above who are scheduled for laparoscopic sleeve gastrectomy and are currently taking statins.
Not a fit: Patients who are pregnant or taking medications that significantly affect simvastatin pharmacokinetics will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized simvastatin dosing for patients undergoing LSG, improving lipid management post-surgery.
How similar studies have performed: While there have been studies on the pharmacokinetics of other statins post-bariatric surgery, this specific investigation into simvastatin is novel and has not been previously explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Planned for laparoscopic sleeve gastrectomy at National University Hospital * Taking statin * Aged 21 or above Exclusion Criteria: * Patient on concomitant treatment with medications/ food/ herbal supplements that may affect the pharmacokinetics of simvastatin: boceprevir, conivaptan, cyclosporine, efavirenz, mitotane, tocilizumab, rifamycin, amiodarone, amlodipine, aprepitant, azithromycin, colchicine, fenofibrate, imatinib, raltegravir, ranolazine, teriflunomide, ticagrelor, fusidic acid, protease inhibitors, telaprevir, telithromycin, gemfibrozil, erythromycin, clarithromycin, carbamazepine, rifampicin, ketoconazole, fluconazole, itraconazole, voriconanzole, diltiazem, verapamil, dexamethasone, prednisolone, phenytoin, ritonavir, indinavir, nelfinavir, bosentan, telithromycin, nefazodone, St John's wort, orlistat, sibutramine and other strong CYP 3A4 inhibitors/ inducers * Pregnant ladies
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Asim Shabbir, MBBS — National University Hospital, Singapore
- Study coordinator: Asim Shabbir, MBBS
- Email: cfsasim@nuhs.edu.sg
- Phone: +65 9820 0814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Hyperlipidemias, pharmacokinetics, simvastatin, bariatric surgery, laparoscopic sleeve gastrectomy