Combining a very low calorie ketogenic diet with naltrexone/bupropion for weight regain after bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a very low calorie ketogenic diet (VLCKD) combined with naltrexone/bupropion (N/B) compared to standard care with N/B alone for individuals who have experienced weight regain after bariatric surgery. The primary goal is to measure the percentage of weight loss at 26 weeks, while secondary endpoints include weight loss percentages at various intervals and patient-reported outcomes related to hunger and cravings. Participants will be monitored for adherence to the diet and medication, as well as the tolerability of the interventions over a year-long period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants eligible for inclusion in this Trial must meet all of the following criteria:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
  3. Miminum 18 years of age at the time of Informed Consent signature
  4. Underwent bariatric surgery (RYGB or SG) with weight regain ≥10% of nadir weight
  5. People without Type 2 diabetes (T2D) • No history, no drugs, HbA1c \< 6,5% and FPG \<126 mg/dl) All participants that are considered for Trial participation, per the above criteria will be documented on the Screening Log, including Screen Failures.

Exclusion Criteria:

* Participants eligible for this Trial must not meet any of the following criteria:

  1. Participant has a history of type 2 diabetes mellitus (also drugs, HbA1c \> 6,5% and FPG \>126 mg/dl)
  2. IFemale who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
  3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
  4. Not willing to sign informed consent
  5. Younger than 18 years of age at the time of Informed Consent signature
  6. Other types of bariatric surgery other than RYGB or SG (including LAGB, BPD)
  7. Underwent bariatric surgery (RYGB or SG) with weight regain \<10% of nadir weight
  8. Contraindication for VLCKD, including CKD stage 4-5, liver cirrhosis, type 1 diabetes mellitus, active gout
  9. Contraindication for NB including the use of opioids, history of CNS tumor or seizures, severe psychiatric disorder or \> 2 psychotropic medications, uncontrolled hypertension
  10. Use of other drugs for weight management (e.g. GLP1Ra) in the last 3 months prior to trial intervention
  11. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified on the Screening Log as Screen Failure.

Where it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting
• AZ Sint-Jan Brugge
  Bruges, West-Vlaanderen, Belgium Not yet recruiting

Study contacts

• Study coordinator: Prof. Dr. R. Vangoitsenhoven
• Email: relaytrial@uzleuven.be
• Phone: +3216344775

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.