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

St. Antonius Hospital

Status and phase: Completed; Phase 4

Conditions: Morbid Obesity

Treatments: Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01519726

MEMO study

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI>40
• undergoing bariatric surgery

Exclusion criteria

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

Trial design

20 participants in 1 patient group

Morbidly obese patients

Experimental group

Treatment:

Drug: Midazolam