Obesitas extreme overweight Obesity
Conditions
Interventions
Adding Mysimba to the BOT program of the Nederlandse Obesitas Kliniek(NOK) and
one-time venapuncture
Sponsors
Zuyderland Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: • Patient is >=18 and = 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 30 kg/m2) • Patient on successful Mysimba steady maintenance dose
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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: 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 who are not able to understand the informed consent form and patient information.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to study the effect of naltrexone/bupropion(Mysimba) in combination with the BOT module compared to the regular BOT module for 22 weeks, the duration of the regular BOT, on weight loss in patients with weight regain after bariatric surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to describe the persistence of therapy of Mysimba after bariatric surgery; to study the used daily dose of Mysimba in patients after bariatric surgery; to evaluate eating behaviour in patient with weight regain after bariatric surgery who used Mysimba compared to patients on the regular module via the YFAS 2.0 questionair; to study adverse effects of Mysimba; to monitor and compare weight loss up to 12 months after the start of Mysimba in both study groups. Tertiary objective(s): These are the tertiary objectives: a) To study bupropion and hydroxybupropion absorption/exposure by measuring steady-state serum levels in bariatric and compare these with steady-state serum levels in obese patients on Mysimba therapy who did not undergo bariatric surgery b) to correlate bupropion and hydroxybupropion steady-state serum levels with effectiveness of Mysimba c) to determine the therapeutic range of bupropion and hydroxybupropion plasma levels in bariatric and obese patients on Mysimba. | — |
Countries
Netherlands
Outcome results
None listed