Bariatric Surgery and Pharmacokinetics of Lisdexamphetamine

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 lisdexamphetamine are investigated.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Olavs University Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lisdexamfetamine dimesylate

Drug

Patients are tested for their normal prescription lisdexamphetamine medication

Other names: Lisdexamfetamine, Vyvanse, Elvanse

Primary outcomes

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

Time frame: From baseline to 1 year postoperatively

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

Alesund Hospital
Namsos Hospital
St. Olavs Hospital
Volvat Medisinsk Senter Stokkan

Registry information

Official study title

Bariatric Surgery and Pharmacokinetics Lisdexamphetamine: BAR-MEDS Lisdexamphetamine

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Apr 13, 2018
Registry last updated: Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed