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

Phase 4CompletedNCT01519726

St. Antonius Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Enrollment

Conditions

Morbid Obesity

Interventions

MidazolamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI\>40 * undergoing bariatric surgery Exclusion Criteria: * use of drug inducing or inhibiting CYP3A4 activity * pregnancy, breastfeeding * renl insufficiency

Locations (1)

St Antonius Hospital

Nieuwegein, Netherlands

Outcomes

Primary Outcomes

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

Time frame: 0.5-2 years

Data from ClinicalTrials.gov

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