NCT03460353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

March 4, 2018

Last Update Submit

June 23, 2025

Conditions

Obesity, Morbid

Keywords

Bariatric surgeryGastrointestinal tractBiological availabilityPharmacokineticsDextroamphetamine

Outcome Measures

Primary Outcomes (1)

  • Dexamphetamine concentration in blood serum (area under curve (AUC))

    From baseline to 1 year postoperatively

Interventions

DexamphetamineDRUG

Patients are tested for their normal prescription dexamphetamine medication

Also known as: Dextroamphetamine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Having previously undergone resections in the GI-tract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs University Hospital

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Magnus Strømmen, MSc

    St. Olavs University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2018

First Posted

March 9, 2018

Study Start

November 2, 2016

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

NO(1)