Midazolam uptake and elimnation in patients with extreme overweight before and 1 year after a gastriv bypass

Conditions: Morbid obesity
Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

Registration Number: EUCTR2011-003293-93-NL

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-20 Morbidly obese subjects scheduled for a gastric bypass 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Before bariatric surgery and 0.5-2 years after bariatric surgery;Main Objective: - To compare midazolam pharmacokinetics in morbidly obese patients before/during a gastric bypass and 0.5-2 year after surgery. ;Primary end point(s): - Difference in midazolam clearance in morbidly obese patients before/during a gastric bypass surgery and 0.5-2 year after surgery.;Secondary Objective: - To compare midazolam pharmacokinetics in morbidly obese patients (both during and 0.5-2 years post a gastric bypass) and in 12 healthy volunteers (from an earlier clinical trial by the Centre for Human Drug Research, CHDR; EudraCT 2009-010331-40). <br>- Assess the influence of both demographic (age, sex) and physiologic covariates (body weight, cardiac output, inflammation markers, distribution of adiposity) on midazolam pharmacokinetics.<br>- Assess midazolam effects by means of sedation scales

Secondary Outcome Measures

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