Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

Launched by HOSPICES CIVILS DE LYON · Mar 6, 2025

Keywords

ClinConnect Summary

The MAMBA trial is a research study that aims to explore the connection between a liver condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH) and certain changes in liver cell structures known as Mitochondria-Associated Membranes (MAMs). Researchers want to understand how these changes in liver cells and other blood cells might contribute to MASH and how bariatric surgery (like sleeve gastrectomy or gastric bypass) could affect them.

To participate in this study, you must be an adult who is planning to undergo bariatric surgery and has been evaluated by a team of medical professionals. You also need to have a liver biopsy planned due to suspected MASH. However, certain conditions, such as active hepatitis infections, autoimmune liver diseases, or a history of excessive alcohol consumption, may disqualify you from joining. If you are eligible, you will be asked to consent to participate and will undergo assessments related to your liver health before and after the surgery. This study is not yet recruiting participants, but it aims to gather important information that could help improve treatments for liver conditions in the future.

Gender

ALL

Eligibility criteria

• * Inclusion Criteria \* :
• • Female or male adult patients
• • Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a sleeve gastrectomy or a gastric bypass.
• • Patient with an indication Indication for intraoperative liver biopsy due to suspected MASH
• • Patient who agrees to be included in the study and who signs the informed consent form,
• • Patient affiliated to a healthcare insurance plan.
• * Exclusion Criteria \* :
• • Patient presenting Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
• • Patient presenting previous or current infection with Hepatitis C
• • Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
• • Patient presenting Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
• • Patient presenting Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
• • Patient presenting Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
• • Patient presenting Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
• • Patient presenting Drug-induced liver disease as defined on the basis of typical exposure and history.
• • Patient presenting Bile duct obstruction as shown by imaging studies.
• • History of ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, methotrexate, amiodarone or tetracycline in the previous 6 months.
• • Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
• • Consommation régulière et/ou excessive d'alcool (plus de 30g/j pour les hommes et plus de 15 g/j pour les femmes) sur une période de plus de 2 ans au cours des 10 dernières années.
• • History of known HIV infection
• • History of type 1 diabetes
• • Pregnant women or breastfeeding mothers\*.
• • Minor patient
• • Patient deprived of liberty,
• • Patients under psychiatric care
• • Patients admitted to a health or social care establishment for purposes other than research
• • Mentally unbalanced patients, under supervision or guardianship,
• • Patients not affiliated to a social security scheme or benefiting from a similar scheme
• • Patient who does not understand French/ is unable to give consent,
• • Patient already included in a trial who may interfere with the study