Fibrosis Lessens After Metabolic Surgery
The FLAMES study investigates effective ways to treat a liver condition called MASH (Metabolic Dysfunction-Associated Steatohepatitis). MASH is a serious liver disease often connected to obesity and affects many people. Currently, there isn't one perfect medicine for MASH, and losing weight is key. This study wants to find out if metabolic (weight-loss) surgery is better than certain new medicines, called incretin-based therapies, at improving the liver damage caused by MASH. About 120 patients with MASH and liver scarring will be randomly split into two groups: one will have surgery, and the other will receive medication. Researchers will then check their liver health after two years.
At a glance
What is this study about?
Many people in the UK live with a condition called Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), which used to be known as non-alcoholic fatty liver disease (NAFLD). This condition means there's too much fat in the liver. For some, it can develop into a more serious problem called Metabolic Dysfunction-Associated Steatohepatitis, or MASH. MASH can lead to scarring (fibrosis) and serious liver damage if not managed.
Being overweight or having obesity, along with conditions like diabetes, are closely linked to MASLD and MASH. While lifestyle changes and weight loss are very important, there isn't a single medication that works for everyone with MASH. This study, called FLAMES (which stands for Fibrosis Lessens After Metabolic Surgery), aims to compare two different ways of treating MASH and its related liver scarring.
The study will look at whether metabolic (weight-loss) surgery is more effective than certain new medicines in a group called incretin-based therapies. Both treatments are known to help with weight loss and can improve health conditions linked to obesity. By comparing them directly, researchers hope to understand which approach leads to better healing and less scarring in the liver for people living with MASH.
Key takeaways
- Compares weight-loss surgery to new medications for a serious liver disease called MASH.
- Aims to see which treatment best reduces liver scarring.
- Involves about 120 patients with MASH and obesity.
- Requires a liver biopsy at the start and end of the two-year study.
- Participation involves being randomly assigned to either surgery or medication.
- The primary study site is in the USA, but it's an international trial.
Who may be eligible?
This study is looking for adults aged 18 to 75 who have both obesity and MASH (a type of liver disease with scarring). To be considered, you would generally need to be a candidate for weight-loss surgery and eligible for general anaesthesia. You'll also need to meet certain health checks, including having specific results from liver tests that suggest scarring.
There are also some specific health requirements related to your weight (your BMI should be between 35 and 70), and you should not have lost a lot of weight in the six months before joining. If you have type 2 diabetes, your condition needs to be stable. Women who could become pregnant would need to use reliable contraception during the study. The medical team will check all these details carefully to see if this 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 aged between 18 and 75?
- Do you have medically diagnosed MASH with liver scarring?
- Are you considered suitable for weight-loss surgery?
- Do you have a Body Mass Index (BMI) typically between 35 and 60?
- Are you able to commit to 2 years of follow-up including liver biopsies?
What does participation involve?
If you decide to take part and are found eligible, you would first provide your informed consent, meaning you understand the study and agree to participate. You would then have a liver biopsy (a small sample taken from your liver) if you haven't had one recently that meets the study's needs. This helps the doctors understand your liver health at the start.
About 120 patients will be randomly split into two groups – like flipping a coin for either treatment. One group will receive metabolic (weight-loss) surgery, and the other will receive medical treatment using incretin-based therapies (medicines like semaglutide, tirzepatide, or liraglutide, which are given as injections or sometimes tablets, potentially with other medicines). Both groups will be followed closely for two years. At the end of these two years, you would have another liver biopsy to see how your liver health has changed. The main study site is in Cleveland, Ohio, USA, but it's a multi-centre international study.
Potential risks and benefits
Locations (22)
- Banner Health CenterVerified postcodePhoenix, United States· Not yet recruiting
- Indiana UniversityVerified postcodeIndianapolis, United States· Not yet recruiting
- Mayo ClinicVerified postcodeRochester, United States· Not yet recruiting
- Cleveland ClinicVerified postcodeCleveland, United States· Recruiting
- Hospital Alemão Oswaldo CruzVerified postcodeSão Paulo, Brazil· Recruiting
- McGill UniversityVerified postcodeMontreal, Canada· Not yet recruiting
- Turku University HospitalVerified postcodeTurku, Finland· Not yet recruiting
- Sri Aurobindo Institute of Medical SciencesVerified postcodeIndore, India· Not yet recruiting
- The Digestive Health InstituteVerified postcodeMumbai, India· Not yet recruiting
- University College DublinVerified postcodeDublin, Ireland· Not yet recruiting
- Università Cattolica del Sacro CuoreVerified postcodeMilan, Italy· Not yet recruiting
- Sapienza Università di RomaVerified postcodeRoma, Italy· Not yet recruiting
Common questions
What is MASH?
MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a serious liver condition where there's fat in the liver, along with inflammation and cell damage, which can lead to scarring.
What is metabolic surgery?
Metabolic surgery is a type of weight-loss surgery that can help people lose a significant amount of weight and improve obesity-related health conditions.
What are incretin-based therapies?
These are a group of medicines, often given as injections, that help control blood sugar and can also lead to weight loss, which can be beneficial for liver conditions.
Will I get to choose my treatment?
No, if you join the study, you will be randomly assigned to either the surgery group or the medication group, like drawing lots or flipping a coin.
How long will I be involved in the study?
If you participate, you will be followed for two years, with assessments at the beginning and the end of this period.
How to find out more
Awwab F Hammad, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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