Actively Recruiting
Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-03-21
62
Participants Needed
2
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent prior to any screening procedures
- Use of highly effective birth control methods (less than 1% failure rate) if applicable
- At least 18 years old at the time of consent
- Underwent bariatric surgery (RYGB or SG) with weight regain of 10% or more from lowest weight
- No history of type 2 diabetes, no diabetes drugs, HbA1c less than 6.5%, and fasting plasma glucose less than 126 mg/dl
You will not qualify if you...
- History of type 2 diabetes or diabetes drugs, HbA1c greater than 6.5%, or fasting plasma glucose greater than 126 mg/dl
- Pregnant, breastfeeding, or intending to become pregnant without effective contraception
- Participation in another interventional trial with investigational medication or device
- Not willing to sign informed consent
- Under 18 years old at time of consent
- Had bariatric surgery other than RYGB or SG (e.g., LAGB, BPD)
- Weight regain less than 10% from lowest weight after bariatric surgery
- Contraindications to VLCKD such as stage 4-5 chronic kidney disease, liver cirrhosis, type 1 diabetes, or active gout
- Contraindications to naltrexone/bupropion including opioid use, history of central nervous system tumor or seizures, severe psychiatric disorder, use of more than two psychotropic medications, or uncontrolled hypertension
- Use of other weight management drugs (e.g., GLP1 receptor agonists) in the last 3 months
- Any condition that may jeopardize safety or compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
2
AZ Sint-Jan Brugge
Bruges, West-Vlaanderen, Belgium, 8000
Not Yet Recruiting
Research Team
P
Prof. Dr. R. Vangoitsenhoven
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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