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

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Antonius Hospital

Nieuwegein, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI>40
undergoing bariatric surgery

Exclusion criteria

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

Treatment and study plan

midazolam

Drug

Primary outcomes

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

Time frame: 0.5-2 years

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Registry information

Official study title

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

Acronym: MEMO

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 27, 2012
Registry last updated: Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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