The goal of this clinical trial is to evaluate the superiority of combined VLCKD, intensive lifestyle intervention and naltrexone/bupropion (N/B) versus standard of care with naltrexone/bupropion on weight loss for people with weight regain after bariatric surgery. The main questions it aims to answer are: Primary endpoint: • The percentage of weight loss at 26 weeks Secondary endpoints: * A weight loss percentage at 10 weeks, 16 weeks and at end of trial (= 52 weeks from start) * A proportion of patients with a weight loss percentage of 5% or more at 10, 16, 26 and 52 weeks * A proportion of patients with a weight loss percentage of 10% or more at 10, 16, 26 and 52 weeks * The time to reach a weight loss percentage of 5% and 10% * The dose of naltrexone/bupropion used at 10, 16, 26 and 52 weeks and at the end of the trial * The tolerability of VLCKD and NB * The adherence to VLCKD and NB * The Patient-Reported Outcome Measures (PROMs) of hunger and cravings at 0, 4, 10, 16, 26 and 52 weeks * The change in fasting glucose, lipids and blood pressure at 10, 16, 26 and 52 weeks Researchers will compare an experimental arm (N/B + Lifestyle + VLCKD) with comparator arm (NB + lifestyle) to see if combined VLCKD, intensive lifestyle and N/B is superior. Participants will: * get NB and lifestyle changes for 26 weeks * follow a VLCKD in the first 10 weeks on top of it, if they belong to the experimental arm * follow NB combined with lifestyle the remaining 16 weeks * be followed-up for an extension of 26 weeks * come to the hospital at week 1, 10, 16, 26, 52
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
62
This is a parallel multicentric longitudinal randomized controlled trial in which prospective data will be collected from the electronic health record. The inclusion and exclusion criteria will be checked and afterwards patients will be randomized to (unblinded) medication only or combination with VLCKD. Both arms include NB and lifestyle changes for 26 weeks but the patients belonging to the experimental arm must follow a VLCKD in the first 10 weeks on top of it. Like the other arm, the remaining 16 weeks will consist of NB combined with lifestyle interventions. Afterwards there is a follow-up extension of 26 weeks.
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGAZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium
NOT_YET_RECRUITINGTo evaluate the superiority of combined VLCKD, intensive lifestyle intervention and naltrexone/bupropion versus standard of care with naltrexone/bupropion on weight loss.
The percentage of weight loss at 26 weeks
Time frame: 26 weeks
• A weight loss percentage at 10 weeks, 16 weeks and at end of trial (= 52 weeks from start)
in %
Time frame: 10,16 and 52 weeks
• A proportion of patients with a weight loss percentage of 5% or more at 10, 16, 26 and 52 weeks
in %
Time frame: 10, 16, 26 and 52 weeks
• A proportion of patients with a weight loss percentage of 10% or more at 10, 16, 26 and 52 weeks
in %
Time frame: 10, 16, 26 and 52 weeks
• The time to reach a weight loss percentage of 5% and 10%
in weeks
Time frame: 52 weeks
• The dose of naltrexone/bupropion used at 10, 16, 26 and 52 weeks and at the end of the trial
the dose is in mg
Time frame: 10, 16, 26 and 52 weeks
• The tolerability of VLCKD
The amount of reported adverse effects, in relation to the achieved VLCKD.
Time frame: 52 weeks
• The tolerability of NB
The amount of reported adverse effects, in relation to the achieved dose level.
Time frame: 52 weeks
• The adherence to VLCKD
The amount meals eaten per day, in accordance to the dietary advice.
Time frame: 52 weeks
• The adherence to NB
The amount of tablets taken per day, in accordance with the medicinal advice.
Time frame: 52 weeks
• The change in fasting glucose at 10, 16, 26 and 52 weeks
fasting glucose in mg/dl
Time frame: at 10, 16, 26 and 52 weeks
• The change in lipids at 10, 16, 26 and 52
lipids in mg/dl
Time frame: at 10, 16, 26 and 52 weeks
• The change in blood pressure at 10, 16, 26 and 52
blood pressure in mmHg
Time frame: at 10, 16, 26 and 52 weeks
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