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NCT03460366 Clinical Trial

Bariatric Surgery and Pharmacokinetics of Enalapril

Obesity, Morbid Clinical Trial

Official title:
Bariatric Surgery and Pharmacokinetics Enalapril: BAR-MEDS Enalapril

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03460366
Other study ID # 2016/1145j
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 2, 2016
Est. completion date October 2026

Study information
Verified date March 2023
Source Norwegian University of Science and Technology
Contact Magnus Strømmen, MSc
Phone 0047 72829970
Email magnus.strommen@stolav.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on enalapril are investigated.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway - Being a Norwegian citizen Exclusion Criteria: - Having previously undergone resections in the GI-tract

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Enalapril
Patients are tested for their normal prescription enalapril medication

Locations
Country Name City State
Norway St. Olavs University Hospital Trondheim

Sponsors (5)
Lead Sponsor Collaborator
Norwegian University of Science and Technology Alesund Hospital, Namsos Hospital, St. Olavs Hospital, Volvat Medisinsk Senter Stokkan

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enalapril concentration in blood serum (area under curve (AUC)) From baseline to 1 year postoperatively
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