Bariatric Surgery and Pharmacokinetics of Lercanidipine

Recruiting

• Conditions: Obesity, Morbid

• Registration Number: NCT03497156
• Lead Sponsor: Norwegian University of Science and Technology

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 lercanidipine are investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
• Being a Norwegian citizen

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Exclusion Criteria

• Having previously undergone resections in the GI-tract

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lercanidipine concentration in blood serum (area under curve (AUC))	From baseline to 1 year postoperatively

Trial Locations

Locations (1)

St. Olavs University Hospital; 🇳🇴 Trondheim, Norway