NCT07748273Not yet recruiting
Rosuvastatin and Losartan Pharmacokinetics After Bariatric Surgery
Comparative Evaluation of Rosuvastatin and Losartan Pharmacokinetics and the Associations Between Gut Microbiota Alterations and Changes in Systemic Drug Exposure in Patients Undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 2 Aug 2026
- Primary completion date
- 15 May 2027
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Diseases
- Obesity
- NCT number
- NCT07748273
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 2 Aug 2026 to the primary completion date, 15 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of drugs that substantially affect rosuvastatin pharmacokinetics and cannot be temporarily discontinued, including cyclosporine, gemfibrozil, or potent OATP1B1/BCRP or CYP2C9 inhibitors.
- Systemic antibiotic use within 3 months or probiotic, prebiotic, or synbiotic use within 4 weeks before sampling.
- Continuous current rosuvastatin or other statin therapy unless medically discontinued with an adequate washout period under physician supervision.
Other illness
- Moderate or severe hepatic impairment, liver enzymes greater than 3 times the upper limit of normal, or Child-Pugh class B or C.
- Clinically relevant baseline hypotension, significant hyperkalemia, renal impairment, or another condition that makes a losartan test dose unsafe.
Other
- Estimated glomerular filtration rate below 30 mL/min/1.73 m².
- Severe postoperative complication preventing oral dosing, including active gastrointestinal leak, intractable vomiting, or severe anastomotic stenosis.
- Pregnancy. Participants of childbearing potential undergo routine preoperative beta-hCG testing.
Who the study is looking for
- Adults aged 18 to 65 years;
- Formal clinical indication for RYGB or sleeve gastrectomy after multidisciplinary assessment;
- Bariatric surgery scheduled and no previous bariatric procedure;
- Able to understand the study and provide written informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.