Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol

• Status: Enrolling by invitation
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the influence of Roux-en Y gastric bypass bariatric surgery (RYGB) on simvastatin and carvedilol kinetic disposition. Furthermore, the expression of CYP3A4 and P-glycoprotein (mRNA) will be assessed in intestinal biopsies before, during and after surgery. Patients with body mass index ≥ 35 kg/mˆ2 who have indication for RYGB bariatric surgery are being investigated (n= 18 for simvastatin and n= 20 for carvedilol).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Natalia Valadares de Moraes
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; University of Sao Paulo
• Treatments: Carvedilol; Metoprolol; Midazolam; polysaccharide-K; Simvastatin

Criteria

Inclusion Criteria:

• Patients of both sex with 18 to 65 years old.

• Patients with body mass index equal or higher than 35 kg/mˆ2.

• Patients with indication to Roux-en-Y gastric bypass bariatric surgery.

Exclusion Criteria:

• Pregnant and lactating patients.

• Patients with serum creatinine higher than 1,5 mg/dL.

• Patients with previous altered coagulation.

• Patients with previous cancer history (on the last year).

• Patients with previous hypersensitivity history to simvastatin or carvedilol.

• Patients who were in use of any anticoagulant (heparin, low molecular weight heparin, aspirin, nonsteroidal antiinflammatory drugs).

• Patients who were in use of CYP3A4 or P-glycoprotein inhibitors or inducers.

• For carvedilol study: patients who were in use of CYP2D6 inhibitors; poor metabolizer phenotype of CYP2D6 and genotyped as CYP2C9*3/*3.

• Patients who disagree to continue the study.