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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39456

Enrollment

Registered

2011-09-05

Start date

2012-01-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesity or overweight

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- Difference in midazolam clearance (CL) in morbidly obese patients before/during bariatric surgery and 0.5-2 year after surgery.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results