Status:
UNKNOWN
Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol
Lead Sponsor:
Natalia Valadares de Moraes
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Sao Paulo
Conditions:
Obesity
Bariatric Surgery
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Obesity affects more than 1 in 3 adults in the U.S. It is commonly associated with reduced quality of life and complications such as metabolic syndrome, heart disease, high blood pressure and sleep di...
Detailed Description
The study is ongoing and eligible subjects are enrolled after signing a written informed consent. Research participants (n=120, in total) include healthy volunteers \[body mass index (BMI) ≤ 25 kg/m2\...
Eligibility Criteria
Inclusion
- Patients of both gender with 18 to 65 years old.
- Healthy volunteers group: body mass index lower or equal to 35 kg/mˆ2.
- Obese group: body mass index higher than 30 kg/mˆ2.
- Post-RYGB group: patients previously submitted to Roux-en-Y gastric bypass bariatric surgery (6-48 months before the study).
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04049786
Start Date
June 1 2019
End Date
August 1 2023
Last Update
February 8 2022
Active Locations (1)
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1
University of Florida
Orlando, Florida, United States, 32827