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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by St. Antonius Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital Identifier:
First received: January 4, 2012
Last updated: January 24, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Morbid Obesity
Drug: Midazolam
Phase 4

Study Type: Interventional
Official Title: CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug

Resource links provided by NLM:

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:
  • Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery [ Time Frame: 0.5-2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morbidly obese patients Drug: Midazolam


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI>40
  • undergoing bariatric surgery

Exclusion Criteria:

  • use of drug inducing or inhibiting CYP3A4 activity
  • pregnancy, breastfeeding
  • renl insufficiency
  Contacts and Locations
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Please refer to this study by its identifier: NCT01519726

St Antonius Hospital Recruiting
Nieuwegein, Netherlands
Contact: Margreke Brill    030-6092612      
Principal Investigator: CAJ Knibbe         
Sponsors and Collaborators
St. Antonius Hospital
  More Information

No publications provided

Responsible Party: Catherijne Knibbe, Professor in Pharmacology, Hospital pharmacist, St. Antonius Hospital Identifier: NCT01519726     History of Changes
Other Study ID Numbers: MEMO study
Study First Received: January 4, 2012
Last Updated: January 24, 2012
Health Authority: Netherlands: CCMO, Central committee on research involving human subjects

Additional relevant MeSH terms:
Obesity, Morbid
Body Weight
Nutrition Disorders
Signs and Symptoms
Adjuvants, Anesthesia
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2015