Cyp3A4 metabolism before and after surgery induced weight loss in morbidly obese patients, using midazolam as a model drug

Completed

Conditions: obesity or overweight
10017998

Registration Number: NL-OMON39456

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- 20 Morbidly obese subjects scheduled for bariatric surgery. We will stratify subjects to 4 weight groups: 100-120 kg; 120-145 kg; 145-170 kg; >170 kg
- Age 18-60 year old

Exclusion Criteria

- Prescription or use of either CYP3A4-activity inducing or decreasing medication.
- Use of product containing grapefruit, wild grape, banpeiyu, pomegranate, star fruit, and black berry within 2 weeks prior to a study visit
- Pregnancy, breastfeeding
- Renal insufficiency
- OSAS

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Difference in midazolam clearance (CL) in morbidly obese patients<br /><br>before/during bariatric surgery and 0.5-2 year after surgery.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>- Difference in midazolam rate of absorption (Ka), bioavailability (F) and<br /><br>volume of distribution (V) in morbidly obese patients before/during bariatric<br /><br>surgery and 0.5-2 year after surgery.<br /><br>- Difference in midazolam pharmacokinetics in morbidly obese patients (both<br /><br>during and 0.5-2 years post bariatric surgery) and 12 healthy volunteers (from<br /><br>an earlier clinical trial by the Centre for Human Drug Research, CHDR; EudraCT<br /><br>2009-010331-40).<br /><br>- Differences in protein binding before and 0.5-2 years after bariatric<br /><br>surgery.</p><br>