Bariatric Surgery and Pharmacokinetics of Ramipril

Bariatric Surgery and Pharmacokinetics of Ramipril: BAR-MEDS Ramipril

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid
• Intervention / Treatment: Drug: Ramipril

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Magnus Strømmen, MSc; Phone Number: 0047 72829970; Email: magnus.strommen@stolav.no

Study Locations

• Norway
  • Trondheim, Norway
    • Recruiting
    • St. Olavs University Hospital
    • Contact: Magnus Strømmen, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ramipril concentration in blood serum (area under curve (AUC))	From baseline to 1 year postoperatively

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Alesund Hospital; Namsos Hospital; Volvat Medisinsk Senter Stokkan
• Investigators: Principal Investigator: Magnus Strømmen, MSc, St. Olavs University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Bariatric surgery; Gastrointestinal tract; Biological availability; Ramipril
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Antihypertensive Agents; Angiotensin-Converting Enzyme Inhibitors; Ramipril
• Other Study ID Numbers: 2016/1145b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No