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Bariatric Surgery and Pharmacokinetics of Venlafaxine

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ClinicalTrials.gov Identifier: NCT03532477
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 18, 2020
Sponsor:
Collaborators:
St. Olavs Hospital
Volvat Medisinsk Senter Stokkan
Namsos Hospital
Alesund Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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 venlafaxine are investigated.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bariatric Surgery and Pharmacokinetics of Venlafaxine: BAR-MEDS Venlafaxine
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


Groups and Cohorts
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Intervention Details:
  • Drug: Venlafaxine
    Patients are tested for their normal prescription metaprolol medication
    Other Names:
    • Venlafaxine Hydrochloride
    • Effexor
    • Trevilor
    • Vandral
    • Dobupal

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

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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)
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT03532477


Contacts
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Contact: Magnus Strømmen, MSc 0047 72829970 magnus.strommen@stolav.no

Locations
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Norway
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
Investigators
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Principal Investigator: Magnus Strømmen, MSc St. Olavs University Hospital
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03532477    
Other Study ID Numbers: 2016/1145y
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Pharmacokinetics
Venlafaxine Hydrochloride
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs