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Clinical Trials/NCT03535376
NCT03535376RecruitingNot Applicable

Bariatric Surgery and Pharmacokinetics of Valsartan: BAR-MEDS Valsartan

Norwegian University of Science and Technology1 site in 1 country12 target enrollmentStarted: November 2, 2016Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
12
Locations
1
Primary Endpoint
Valsartan concentration in blood serum (area under curve (AUC))
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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 valsartan are investigated.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Valsartan concentration in blood serum (area under curve (AUC))

Time Frame: From baseline to 1 year postoperatively

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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