CYP3A4 Metabolism Before and After Surgery Induced Weight... | NCT01519726

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

NCT01519726

Sponsor

St. Antonius Hospital

Status

Completed

Last Update Posted

Apr 4, 2019Actual

Enrollment

20Estimated

Phase

Phase 4

Conditions

Morbid Obesity

Interventions

Midazolam

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 4, 2012

First Submission Date that Met QC Criteria

Jan 24, 2012

First Posted Date

Jan 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2019

Last Update Posted Date

Apr 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Catherijne Knibbe, Professor in Pharmacology, Hospital pharmacist, St. Antonius HospitalPrincipal Investigator

Lead Sponsor

St. Antonius HospitalOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Morbidly obese patients	Experimental		Drug: Midazolam

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug		Morbidly obese patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in midazolam clearance in morbidly obese patients before and 0.5-2 years after surgery		0.5-2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>40
undergoing bariatric surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Antonius Hospital		Nieuwegein			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided