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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01519726
Recruitment Status : Unknown
Verified January 2012 by Catherijne Knibbe, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : January 27, 2012
Last Update Posted : January 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Drug: Midazolam Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Official Title: CYP3A4 Metabolism Before and After Surgery Induced Weight Loss in Morbidly Obese Patients Using Midazolam as a Model Drug
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Morbidly obese patients Drug: Midazolam


Outcome Measures

Primary Outcome Measures :
  1. Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery [ Time Frame: 0.5-2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI>40
  • undergoing bariatric surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519726


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

Responsible Party: Catherijne Knibbe, Professor in Pharmacology, Hospital pharmacist, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT01519726     History of Changes
Other Study ID Numbers: MEMO study
First Posted: January 27, 2012    Key Record Dates
Last Update Posted: January 27, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action