NCT03440190

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 we investigate the pharmacokinetic effects of bariatric surgery on methylphenidate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

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

January 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3.5 years

First QC Date

February 14, 2018

Last Update Submit

June 23, 2025

Conditions

Obesity, Morbid

Keywords

Bariatric surgeryGastrointestinal tractBiological availabilityPharmacokineticsMethylphenidate

Outcome Measures

Primary Outcomes (1)

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

    From baseline to 1 year postoperatively

Interventions

MethylphenidateDRUG

Patients are tested for their normal prescription methylphenidate medication

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

Methylphenidate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

February 14, 2018

First Posted

February 22, 2018

Study Start

January 2, 2018

Primary Completion

June 25, 2021

Study Completion

June 25, 2021

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

NO(1)