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

NCT ID: NCT01519726

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Study Groups

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Morbidly obese patients

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Interventions

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Midazolam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI\>40
* undergoing bariatric surgery

Exclusion Criteria

* use of drug inducing or inhibiting CYP3A4 activity
* pregnancy, breastfeeding
* renl insufficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Catherijne Knibbe

Professor in Pharmacology, Hospital pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEMO study

Identifier Type: -

Identifier Source: org_study_id

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