- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460353
Bariatric Surgery and Pharmacokinetics of Dexamphetamine
March 24, 2023 updated by: Norwegian University of Science and Technology
Bariatric Surgery and Pharmacokinetics Dexamphetamine: BAR-MEDS Dexamphetamine
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 dexamphetamine are investigated.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Trondheim, Norway
- Recruiting
- St. Olavs University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dexamphetamine concentration in blood serum (area under curve (AUC))
Time Frame: From baseline to 1 year postoperatively
|
From baseline to 1 year postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2016
Primary Completion (Anticipated)
October 1, 2026
Study Completion (Anticipated)
October 1, 2026
Study Registration Dates
First Submitted
March 4, 2018
First Submitted That Met QC Criteria
March 4, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Obesity, Morbid
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Dextroamphetamine
Other Study ID Numbers
- 2016/1145i
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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