A Phase 4 interventional study of Simvastatin in Obesity and Hyperlipidemias, sponsored by National University Hospital, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by National University Hospital, Singapore · Phase 4, Interventional, and Treatment
This study aims to investigate the change in systemic exposure of simvastatin post LSG.
Morbid obesity (Body mass index > 40 kg/m2 or 35-39 kg/m2 with comorbidity; 37.5 kg/m2 for Asians) is a growing global health issue. Bariatric surgery is the only intervention that has demonstrated sustainable reduction in weight and comorbidities.1,2 Among the various bariatric procedures, laparoscopic sleeve gastrectomy (LSG) has rapidly gained popularity worldwide.3,4 Physiological alterations following LSG include reduction in gastrointestinal surface and reduced retention of food. Bioavailability of drugs may be affected but published literature in this area is sparse and studies are usually small and uncontrolled.5-7 Moreover, some reports concerning gastric banding and jejunoileal bypass are no longer practiced because of the associated risk. In general, bioavailability of orally administered drug changes with a reduction in gastrointestinal area. While Kroll et al showed slight increase in area under curve of rivaroxaban post bariatric surgery8, Skottheim et al demonstrated significant but variable change in systemic exposure of atorvastatin after gastric bypass (from threefold decrease to twofold increase) that diminished but was sustained with time (21-45 months post gastric bypass)9-10.
No study has investigated the change in pharmacokinetics of simvastatin post LSG.
Simvastatin is a widely-used lipid-lowering agent with a low bioavailability of 5% due to the extensive first pass metabolism.11 As simvastatin undergoes hydrolysis in the stomach to the active form12, it is postulated that bioavailability of simvastatin will decrease after LSG.13-15 A decrease in bioavailability may be associated with reduced efficacy. Authors of review articles suggested choosing an alternative agent to simvastatin post bariatric surgery. However, such recommendation is largely based on theoretical concern rather than solid evidence.14,15 A previous study attempted to model the pharmacokinetics of simvastatin post Roux-en-Y and biliopancreatic diversion with duodenal switch.13 The data is not applicable to LSG and the model did not take into account of the pH-dependent hydrolysis. This will be the first study aiming to investigate the change in systemic exposure of simvastatin post LSG.
821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.
This study's planned enrollment of 10 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
simvastatin 20mg once
Drug: Simvastatin
* The subject will take simvastatin 20mg at 0 h (after stopping simvastatin for 5 days). 5 mL of blood will be sampled at 0 h, 1 h, 2 h, 3 h, 5 h, 7 h. * There will be 2 blood sampling sessions: 1 before and the other 3 months after surgery.
Also known as: Study arm
Area Under Curve (AUC) of simvastatin
Ratio of AUC of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Maximum serum concentration (Cmax) of simvastatin
Ratio of Cmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Time at which maximum serum concentration (Tmax) of simvastatin
Ratio of Tmax of simvastatin for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Area Under Curve (AUC) of simvastatin acid
Ratio of AUC of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Maximum serum concentration (Cmax) of simvastatin acid
Ratio of Cmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Time at which maximum serum concentration (Tmax) of simvastatin acid
Ratio of Tmax of simvastatin acid for each subject before and 3 months after surgery will be calculated, the mean ratio will be reported
Time frame: baseline (before surgery). 3 months after surgery
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No plan to share IPD
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National University Hospital, Singapore