Status:
UNKNOWN
Use of Mysimba in Patients With Weight Regain After Bariatric Surgery
Lead Sponsor:
Zuyderland Medisch Centrum
Collaborating Sponsors:
Nederlandse Obesitas Kliniek
Conditions:
Obesity, Morbid
Bariatric Surgery Candidate
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief Summary
Although bariatric surgery is currently the most effective treatment for morbid obesity, weight regain occurs in 16-37% of the patients (1). Weight regain is not regularly treated with antiobesity med...
Detailed Description
Throughout the years it has become clear that lifestyle intervention is the cornerstone for all types of bariatric treatment. Educating patients about behaviour, physical activity and intake strategie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Anatomical or surgical abnormalities for which revisional surgery is indicated.
- Use of the following medication Monoamino-oxidase inbibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- Pregnancy or breastfeeding
- Patients suffering from:
- unregulated hypertension
- a tumour in the central nervous system
- severe liver failure
- end stage kidney failure
- Patients suffering from or with a history of insults
- Patients with a history of:
- bipolar disease
- bulimia or anorexia nervosa
- Patients withdrawing from alcohol or benzodiazepines
- Patients who are not able to understand the informed consent form and patient information.
Key Trial Info
Start Date :
March 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04902625
Start Date
March 21 2023
End Date
March 1 2025
Last Update
May 30 2023
Active Locations (1)
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1
Zuyderland Medical Center
Heerlen, Limburg, Netherlands, 6419 PC