Effects of Sleeve Gastrectomy and Roux-en-Y Gastric Bypass on Escitalopram Pharmacokinetics: A Cohort Study.
Georgios Schoretsanitis, Magnus Strømmen, Hege-Merete Krabseth...
https://pubmed.ncbi.nlm.nih.gov/37363832Actively Recruiting
Age: 18Years - 70Years
All Genders
ID03460379
Bariatric Surgery and Pharmacokinetics Escitalopram: BAR-MEDS Escitalopram
Led by Norwegian University of Science and Technology · Updated on 2023-03-27
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Norwegian University of Science and Technology
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how bariatric surgery, such as gastric bypass or sleeve gastrectomy, affects the way the body processes the medication escitalopram. This study focuses on understanding changes in drug absorption and metabolism caused by surgical alterations to the stomach and digestive system in adults with morbid obesity. The goal is to learn how these surgeries impact the blood levels of escitalopram over time. Participants in this observational study include adults preparing for bariatric surgery in Central Norway who are currently taking escitalopram as prescribed. The study tracks escitalopram concentration in blood serum from before surgery up to one year afterward. There are no treatment groups or placebo controls, as the study observes natural changes in medication levels related to the surgery. Throughout the study, participants have their blood tested to measure escitalopram concentration at multiple points from baseline to one year after surgery. Researchers monitor how the surgery influences drug availability and metabolism. The total participation period spans about one year postoperatively, with assessments focused on pharmacokinetic changes related to the surgical procedures.
CONDITIONS
Brief Title
Bariatric Surgery and Pharmacokinetics of Escitalopram
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
- Being a Norwegian citizen
- Age between 18 and 70 years
- Taking escitalopram medication as prescribed
You will not qualify if you...
- Having previously undergone resections in the gastrointestinal tract
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to 1 week
Participants undergo gastric bypass or sleeve gastrectomy surgery and receive immediate post-operative care.
Monitoring
Duration - From baseline to 1 year postoperatively
Participants taking escitalopram are monitored for escitalopram concentration in blood serum from baseline to 1 year after surgery.
Multiple visits over 1 year
Trial Site Locations
Total: 1 location
1
St. Olavs University Hospital
Trondheim, Norway
Actively Recruiting
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Research Team
M
Magnus Strømmen, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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