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NCT03440177 Clinical Trial

Bariatric Surgery and Pharmacokinetics of Ramipril

Obesity, Morbid Clinical Trial

Official title:
Bariatric Surgery and Pharmacokinetics of Ramipril: BAR-MEDS Ramipril

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03440177
Other study ID # 2016/1145b
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date December 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 we investigate the pharmacokinetic effects of bariatric surgery on ramipril.

Recruitment information / eligibility
Status Recruiting
Enrollment 12
Est. completion date December 2026
Est. primary completion date December 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:
• Ramipril
Patients are tested for their normal prescription ramipril 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 Ramipril concentration in blood serum (area under curve (AUC)) From baseline to 1 year postoperatively
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