Improving Efficacity of Sleeve Gastrectomy With Naltrexone/Bupropion Extended-release Tablet
This study aims to find out if combining a special medication called Naltrexone/Bupropion with a type of weight-loss surgery, called sleeve gastrectomy, leads to better results for patients. Researchers want to see if this combination helps people lose more weight over 12 and 24 months, improves health problems often linked to obesity (like diabetes or high blood pressure), and helps improve eating habits. Patients will be randomly split into two groups: one will receive the Naltrexone/Bupropion after surgery, and the other will receive a dummy pill (placebo). Both groups will also get professional advice on diet and lifestyle. The study will last for 24 months after starting the medication.
At a glance
What is this study about?
This research study is investigating new ways to achieve better outcomes for people who have had weight-loss surgery, specifically a sleeve gastrectomy. This type of surgery helps people lose a significant amount of weight, but researchers are always looking for ways to improve these results further. This study wants to see if adding a specific medication, a combination of Naltrexone and Bupropion, after the surgery helps people manage their weight more effectively.
The main goals are to see if patients who receive this medication after surgery lose more weight compared to those who don't. They'll be looking at how much weight people lose after one and two years. They also want to understand if this combined approach helps to clear up other health problems often linked to obesity, such as type 2 diabetes or high blood pressure. Finally, the study will explore if taking this medication helps people develop healthier eating behaviours.
Ultimately, by comparing the group receiving the study medication with a group receiving a dummy pill, researchers hope to understand if this drug can offer a significant advantage to patients undergoing sleeve gastrectomy, leading to better long-term health and weight management.
Key takeaways
- This study investigates if a drug helps weight loss after sleeve gastrectomy.
- It compares the drug to a dummy pill over two years.
- Both groups receive diet and lifestyle support.
- A BMI of 30+ with health issues, or 35+ without, is generally needed.
- Certain health conditions or medications would prevent participation.
- Participation involves taking a study drug and regular check-ups.
Who may be eligible?
To join this study, you generally need to be between 18 and 65 years old. For adults considering weight-loss surgery, you would typically need to have a Body Mass Index (BMI) of 30 or higher if you also have health issues linked to obesity, or a BMI of 35 or higher even if you don't have those specific health problems.
There are also some reasons why you might not be able to take part. For example, if you've already had weight-loss surgery before, or if you're pregnant or planning to become pregnant in the next two years. You also can't be taking other weight-loss medications or certain types of pain relief called opioids.
Other reasons you might not be eligible include having uncontrolled high blood pressure, a history of seizures, severe liver or kidney disease, or certain eating disorders like bulimia or anorexia. If you use a heart pacemaker or take specific medications that react badly with the study drug, you also wouldn't be able to participate. Your doctor will carefully check all these points to see if the study is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 65 years old?
- Is your BMI 30 or higher (with obesity-related health issues) or 35 or higher (without these issues)?
- Have you NOT had weight-loss surgery before?
- Are you NOT pregnant or planning to be in the next two years?
- Are you NOT taking other weight-loss medications or certain pain medications (opioids)?
- Do you NOT have a history of seizures or specific severe health problems?
What does participation involve?
If you decide to take part in this study, you'll first have the sleeve gastrectomy surgery. About one month after your surgery, you will start taking a medication. This will either be the study drug (Naltrexone/Bupropion) or a dummy pill (placebo) – you won't know which one you're receiving, and it will be decided randomly, like flipping a coin. You'll gradually increase the dose of your medication over time.
You will continue taking this medication or placebo for 24 months (two years). Throughout this period, both groups of participants will also receive ongoing support and advice on healthy eating and lifestyle changes. You will have regular check-ups with the study team to monitor your progress, weight loss, any changes in your health conditions, and how you are feeling. The study will involve several visits to the clinic over these two years, for assessments and to collect information about your health and eating habits.
Potential risks and benefits
Locations (1)
- Criucpq-UlVerified postcodeQuébec, Canada· Recruiting
Common questions
What is Naltrexone/Bupropion?
It's a combination of two medicines that is sometimes used to help people with weight management.
What is a sleeve gastrectomy?
It's a type of weight-loss surgery where a large part of the stomach is removed, making it smaller.
Will I know if I'm getting the drug or a dummy pill?
No, you won't know. This is called 'blinding' and helps ensure fair results.
How long will I take the study medicine?
You will take the medicine or dummy pill for 24 months, which is two years.
What kind of support will I get?
Both groups in the study will receive advice and support on diet and healthy living.
How to find out more
Mélanie Nadeau
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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