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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by St. Antonius Hospital
Sponsor:
Information provided by (Responsible Party):
Catherijne Knibbe, St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT01519726
First received: January 4, 2012
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
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:
Weight Loss
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014