This prospective, open-label, non-randomized pharmacokinetic study will evaluate how Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy affect systemic exposure to single oral test doses of rosuvastatin and losartan. Sixty adults scheduled for bariatric surgery will enter one of two parallel groups according to the clinically selected operation (30 RYGB and 30 sleeve gastrectomy). Each participant will receive rosuvastatin 10 mg and losartan 25 mg once within 30 days before surgery and again approximately 12 weeks after surgery. Plasma samples collected before dosing and at 1.5 and 4 hours after dosing will be used with maximum a posteriori Bayesian estimation to estimate individual pharmacokinetic parameters. In the 30-participant RYGB group only, paired stool samples will be used to explore gut microbiota and untargeted fecal metabolomic changes. The primary objective is to compare within-participant changes and between-procedure differences in drug exposure after bariatric surgery.
Inclusion Criteria:
Exclusion Criteria:
wsalgado@fmrp.usp.br
Participants scheduled for clinically indicated laparoscopic RYGB receive a single oral research dose of rosuvastatin 10 mg plus losartan 25 mg within 30 days before surgery and again approximately 12 weeks after surgery. Plasma is collected at 0, 1.5, and 4 hours at each visit. Paired stool samples are collected before and after surgery for microbiome and untargeted metabolomics analyses.
Participants scheduled for clinically indicated laparoscopic sleeve gastrectomy receive the same single oral research doses and pharmacokinetic plasma sampling schedule before and approximately 12 weeks after surgery. Stool collection and microbiome/metabolomics analyses are not performed in this group.
joaoalmiroff@gmail.com+5516988250557
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