Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bariatric Surgery and Pharmacokinetics of Valsartan

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.
 
ClinicalTrials.gov Identifier: NCT03535376
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : June 13, 2019
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 valsartan are investigated.

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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bariatric Surgery and Pharmacokinetics of Valsartan: BAR-MEDS Valsartan
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

Drug Information available for: Valsartan

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Valsartan
    Patients are tested for their normal prescription valsartan medication
    Other Names:
    • Diovan
    • Kalpress
    • Tareg
    • Provas
    • Miten

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Biospecimen Retention:   Samples With DNA
Blood

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03535376


Contacts
Layout table for location contacts
Contact: Magnus Strømmen, MSc 0047 72829970 magnus.strommen@stolav.no

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Magnus Strømmen, MSc St. Olavs University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03535376     History of Changes
Other Study ID Numbers: 2016/1145w
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Valsartan
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action