CYP3A4 Metabolism Before and After Surgery Induced Weight Loss Using Midazolam as Model Drug

Morbid Obesity Clinical Trial

— MEMO  

Official title:

CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519726
• Other study ID #: MEMO study
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2019
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI>40

• undergoing bariatric surgery

Exclusion Criteria:

• use of drug inducing or inhibiting CYP3A4 activity

• pregnancy, breastfeeding

• renl insufficiency

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Drug:
• Midazolam

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery		0.5-2 years