Applying Mysimba in patients with weight regain after bariatric surgery

Not yet recruiting

• Conditions: Obesity; Obesity Surgery

• Registration Number: 2024-516645-39-01
• Lead Sponsor: Zuyderland Medisch Centrum Stichting

Brief Summary

Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 157

Inclusion Criteria

Patient is ≥18 and <75 years old

BMI before surgery was ≥ 35.0 kg/m2

Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)

Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose

Exclusion Criteria

Anatomical or surgical abnormalities for which revisional surgery is indicated.

Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)

Pregnancy or breastfeeding

Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure

Patients suffering from or with a history of insults

Patients with a history of: o bipolar disease o bulimia or anorexia nervosa

Patients withdrawing from alcohol or benzodiazepines

Patients with excessive use of alcohol or drugs

Patients who are not able to understand the informed consent form and patient information.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.		The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.

Trial Locations

Locations (1)

Zuyderland Medisch Centrum Stichting; 🇳🇱 Heerlen, Netherlands

Zuyderland Medisch Centrum Stichting

🇳🇱Heerlen, Netherlands

J.W. Greve

Site contact

+31884599719

grevejw@gmail.com