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New treatment option for Weight Regain Post Bariatric Surgery
Official title Naltrexone/Bupropion With or Without Very Low Calorie Ketogenic Diet for Weight Regain After Bariatric Surgery
ClinicalTrials.gov ID: NCT06881485
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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...
- Miminum 18 years of age at the time of Informed Consent signature
- Underwent bariatric surgery (RYGB or SG) with weight regain ≥10% of nadir weight
You likely can't join if
- Participants eligible for this Trial must not meet any of the following criteria:
- Participant has a history of type 2 diabetes mellitus (also drugs, HbA1c \> 6,5% and FPG \>126 mg/dl)
- IFemale who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective...
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device
- Not willing to sign informed consent
- Younger than 18 years of age at the time of Informed Consent signature
See the full eligibility criteria
- Participants eligible for inclusion in this Trial must meet all of the following criteria:
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 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...
- Miminum 18 years of age at the time of Informed Consent signature
- Underwent bariatric surgery (RYGB or SG) with weight regain ≥10% of nadir weight
- 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...
- Participants eligible for this Trial must not meet any of the following criteria:
- Participant has a history of type 2 diabetes mellitus (also drugs, HbA1c \> 6,5% and FPG \>126 mg/dl)
- 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
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device
- Not willing to sign informed consent
- Younger than 18 years of age at the time of Informed Consent signature
- Other types of bariatric surgery other than RYGB or SG (including LAGB, BPD)
- Underwent bariatric surgery (RYGB or SG) with weight regain \<10% of nadir weight
- Contraindication for VLCKD, including CKD stage 4-5, liver cirrhosis, type 1 diabetes mellitus, active gout
- Contraindication for NB including the use of opioids, history of CNS tumor or seizures, severe psychiatric disorder or \> 2 psychotropic medications, uncontrolled hypertension
- Use of other drugs for weight management (e.g. GLP1Ra) in the last 3 months prior to trial intervention
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Vlaams-Brabant, Belgium
- Bruges, West-Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Vlaams-Brabant, Belgium; Bruges, West-Vlaanderen, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.