Back to resultsCYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug (MEMO)
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Midazolam
Sponsored by
About this trial
This is an interventional trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI>40
- undergoing bariatric surgery
Exclusion Criteria:
- use of drug inducing or inhibiting CYP3A4 activity
- pregnancy, breastfeeding
- renl insufficiency
Sites / Locations
- St Antonius Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Morbidly obese patients
Arm Description
Outcomes
Primary Outcome Measures
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01519726
Brief Title
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
Acronym
MEMO
Official Title
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
5. Study Description
Brief Summary
Before and during bariatric surgery patients are given oral and i.v. midazolam, respectively and blood samples are drawn to establish midazolam time-concentration profiles. After 0.5-2 years, and substantial weight loss, oral and i.v. midazolam are administered once more and blood samples are taken again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Study Phase
Phase 4
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morbidly obese patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Midazolam
Primary Outcome Measure Information:
Title
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery
Time Frame
0.5-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI>40
undergoing bariatric surgery
Exclusion Criteria:
use of drug inducing or inhibiting CYP3A4 activity
pregnancy, breastfeeding
renl insufficiency
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug
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