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Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery

NCT06881485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-03-21

No results posted yet for this study

Summary

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

  • Weight Regain Post Bariatric Surgery
  • Obesity (Disorder)

Interventions

OTHER

Very Low Calorie Diet

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881485 on ClinicalTrials.gov