Original Query: Recruiting Studies
Previous Study | Return to List | Next Study

Bariatric Surgery and Pharmacokinetics of Dexamphetamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03460353
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
St. Olavs Hospital
Volvat Medisinsk Senter Stokkan
Namsos Hospital
Alesund Hospital
Information provided by (Responsible Party):
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 dexamphetamine are investigated.

Condition or disease Intervention/treatment
Obesity, Morbid Drug: Dexamphetamine

Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bariatric Surgery and Pharmacokinetics Dexamphetamine: BAR-MEDS Dexamphetamine
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Dexamphetamine
    Patients are tested for their normal prescription dexamphetamine medication
    Other Name: Dextroamphetamine

Primary Outcome Measures :
  1. Dexamphetamine concentration in blood serum (area under curve (AUC)) [ Time Frame: From baseline to 1 year postoperatively ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03460353

Contact: Magnus Strømmen, MSc 0047 72829970

St. Olavs University Hospital Recruiting
Trondheim, Norway
Contact: Magnus Strømmen, MSc         
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Volvat Medisinsk Senter Stokkan
Namsos Hospital
Alesund Hospital
Principal Investigator: Magnus Strømmen, MSc St. Olavs University Hospital

Responsible Party: Norwegian University of Science and Technology Identifier: NCT03460353     History of Changes
Other Study ID Numbers: 2016/1145i
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Bariatric surgery
Gastrointestinal tract
Biological availability

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents