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

NARecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

January 20, 2025

Primary Completion Date

January 1, 2027

Study Completion Date

January 1, 2027

Conditions
Weight Regain Post Bariatric SurgeryObesity (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.

Trial Locations (2)

3000

RECRUITING

UZ Leuven, Leuven

8000

NOT_YET_RECRUITING

AZ Sint-Jan Brugge, Bruges

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER