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

Phase 4

Completed

• Conditions: Morbid Obesity
• Interventions: Drug: Midazolam

• Registration Number: NCT01519726
• Lead Sponsor: St. Antonius Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-27
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• BMI>40
• undergoing bariatric surgery

Exclusion Criteria

• use of drug inducing or inhibiting CYP3A4 activity
• pregnancy, breastfeeding
• renl insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Morbidly obese patients	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery	0.5-2 years

Trial Locations

Locations (1)

St Antonius Hospital; 🇳🇱 Nieuwegein, Netherlands