Bariatric Surgery and Pharmacokinetics of Methylphenidate

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03440190
Collaborator
St. Olavs Hospital (Other), Volvat Medisinsk Senter Stokkan (Other), Namsos Hospital (Other), Alesund Hospital (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
12 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Bariatric Surgery and Pharmacokinetics Methylphenidate: BAR-MEDS Methylphenidate
Actual Study Start Date :
Jan 2, 2018
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Methylphenidate concentration in blood serum (area under curve (AUC)) [From baseline to 1 year postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Olavs University Hospital Trondheim Norway

Sponsors and Collaborators

  • Norwegian University of Science and Technology
  • St. Olavs Hospital
  • Volvat Medisinsk Senter Stokkan
  • Namsos Hospital
  • Alesund Hospital

Investigators

  • Principal Investigator: Magnus Strømmen, MSc, St. Olavs University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT03440190
Other Study ID Numbers:
  • 2016/1145c
First Posted:
Feb 22, 2018
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022