The effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol from an immediate release tablet in female bariatric patient volunteers: a single oral dose study before and after surgery

Completed

• Conditions: Roux-en-Y gastric bypass; weight loss surgery; 10017998

• Registration Number: NL-OMON38769
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Female gender
- Age 18-50 years
- Scheduled for Roux-en-Y gastric bypass surgery
- Good liver and kidney function
- Normal ECG
- Intermediate or extensive CYP 2D6 metabolizer, evidenced by genotyping.

Exclusion Criteria

- Pregnancy
- Smoking
- Alcohol: more than 7 drinks a week or 4 or more drinks during a single occasion (12)
- Use of alcohol during the period 24 hours before until 48 hours after the start of each phase of the study
- Use of metoprolol
- The use of CYP 2D6 inhibiting, inducing or metabolising drugs
- The use of drugs that may interact with metoprolol
o Calcium antagonist
o Lidocaine
o Digoxin
- An existing contraindication for the use of metoprolol (8)
o Sick-sinus syndrome
o Second and third degree heart block
o Systolic blood pressure less than 100 mmHg
o Cardiogenic shock
o Sinus bradycardia
o Cardiac failure, overt
o Cardiac failure, moderate to severe
o Untreated pheochromocytoma
o Heart rate less than 45 beats/minute
o First degree heart block (P-R interval 0.24 sec or greater)
o Severe bronchial asthma or a history of severe bronchospasm
o Hypersensitivity to metoprolol, related derivatives, other beta-blockers, or any component of the product
o Severe peripheral arterial circulatory disorders
- Previous surgery of the upper gastrointestinal tract
- Disease or any other condition that may interfere with gastrointestinal absorption
- Suffering from dumping syndrome after RYGB surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Parameters that will be determined before and after surgery are Cmax, Tmax, and<br /><br>AUC0-10 of metoprolol and its main active metabolite a-OH metoprolol.<br /><br><br /><br>The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and a-OH<br /><br>metoprolol.<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and<br /><br>its metabolite after and before.<br /><br><br /><br><br /><br>Other study parameters<br /><br>Blood pressure and heart rate measured at t = 0, 2, 4, 8 and 10 hours after<br /><br>intake of metoprolol.<br /><br><br /><br>Further analysis<br /><br>After completion of the other pharmacokinetic study with metoprolol controlled<br /><br>release tablet relevant parameters may be compared for further analysis.</p><br>